Recall Z-1156-2007 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Datascope Corporation
Precision Bipolar Device ClearGlide EVH Small (endoscopic vessel harvesting system) The kit included three Precision BiPolar Devices, an Optical Vessel Dissector, a Small Ultra Retractor and a Vessel Dissector. Datascope Cardiac Assist Sterile R Manufactured for: Datascope Cardiac Assist 15 Law Drive Fairfield, NJ 07004
| Date | Aug 9, 2007 (initiated May 7, 2007) |
| Status | Terminated |
| Reason | Datascope has experienced a higher than usual number of reports involving the Precision Bipolar Device. Reports include the locking or sticking of the buttons of the device which operate the jaws, particularly when a side load is placed on the shaft of the device. |
| Root cause | Other |
| Action | Letters were sent to all hospitals, (contact: Hospital Administrators) the week of May 7, 2007 (certified mail, Return Receipt requested) with Urgent Medical Device Field Correction. The letter requests that all potential users of the devices at the institution be mdae aware of the situation. The letter instructs clinicians what to do if they experience problems with locking buttons of the Precision Device and also if the device is clamped closed on a vein branch and cannot be opened. Institutions are also requested to sign and return a postal card acknowledging receipt of the Field Correct n |
| Quantity | 1008 |
| Distribution | Worldwide, including USA, Belgium, the Netherlands, and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003587 | CLEARGLIDE PRECISION BIPOLAR DEVICE ETHICON, Inc., Dec 4, 2000 |