FDA Adverse Event
Malfunction
Summary report: N
MICROLINE
MDR report key: 793503
·
Received November 28, 2006
Report
- Report Number
- 793503
- Event Type
- Malfunction
- Date Received
- November 28, 2006
- Date of Event
- November 21, 2006
- Report Date
- November 27, 2006
- Manufacturer
- ADVANCED MED SURG CONCEPTS, INC
- Product Code
- GDO
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IN, US
Narratives
Description of Event or Problem · 1
A PATIENT WAS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY. DURING THE PROCEDURE, THE CLIP APPLIER HAD A RED STOPPER PIECE WHICH JAMMED INTO THE CLIP CHANNEL DISTAL TIP PREVENTING THE ADVANCEMENT OF A CLIP. SURGICAL TEAM WAS TRYING THIS NEW PRODUCT. THIS APPLIER WAS NEVER INTRODUCED INTO THE PATIENT. ANOTHER APPLIER WAS UTILIZED WITH NO UNTOWARD EVENT. SALES REPRESENTATIVE IN THE OR SUITE AT THE TIME OF EQUIPMENT FAILURE. INSTRUMENT RETURNED TO THE COMPANY VIA SALES REPRESENTATIVE FOR PRODUCT EVALUATION.I HAVE DONE SOME INVESTIGATION ON THIS PRODUCT. THE HANDLE AND THE RED TIP ARE REUSABLE. NEITHER OF THESE PRODUCTS HAVE ANY SPECIAL PACKAGING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROLINE | CLIP APPLIER | GDO | ADVANCED MED SURG CONCEPTS, INC | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | NO OTHER THERAPIES |