Recall Z-1530-2020 ยท GWG Endoscope, Neurological
Karl Storz Endoscopy
Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope
| Date | Aug 27, 2019 |
| Status | Open, Classified |
| Reason | During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information, specified for the STERIS System 1E (SS1E) sterilization method within the instruction manual is incorrect. If the user uses SS1E to sterilize the impacted scopes and referred to the manual concerning the QCK information, the sterility of reprocessed scope cannot be guaranteed. |
| Root cause | Error in labeling |
| Action | On 8/27/2019 the firm sent an "Urgent Medical Device - Correction" letter detailing the recall was mailed to consignees. In addition to addressing the recall it asked customers to do the following: 1. If you use STERIS SS1E to sterilize the above scopes, and if you selected the specific QCK and tray according to the KARL STORZ Instruction Manuals, please be aware that the sterility of the scope cannot be guaranteed and that you should consider taking necessary actions to address any patient safety concerns. 2. Other than STERIS SS1E system, these scopes can also be sterilized via EtO, STE |
| Quantity | 73 scopes |
| Distribution | US: AL, AZ, CA, CO, CT, DE, FL, GA, IL, IN, MA, MD, MI, MN, MO, NC, NH, NJ, OH, OR, PA, SC, TN, TX, VA, WA, WI, WV, OUS: Canda |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002788 | KSEA NEURO-FIBERSCOPE KARL STORZ Endoscopy-America, Inc., Oct 23, 2000 |