FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH ENDOSCOPIC ARTICULATING MULTIFEED STAPLER
MDR report key: 42800
·
Received October 2, 1996
Report
- Report Number
- 1527736-1996-00200
- Event Type
- Malfunction
- Date Received
- October 2, 1996
- Report Date
- September 26, 1996
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GAG
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A1,2,3,4;B3,6,7;D10: INFORMATION NOT PROVIDED BY AFFILIATE. 8/30/96 CONTACTED AFFILIATE "SPECIFIC NATURE OF THE MALFUNCTION?" DSH. 9/6/96 INFO REC'D-DSH. 9/6/96 STAPLES WON'T CLOSE, LAST STAPLES WOULD NOT CLOSE DURING TEST. DSH. D5,6;H4: INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
Description of Event or Problem · 1
THE DEVICE WAS USED DURING AN UNK PROCEDURE. IT WAS REPORTED BY THE REP THE INSNTRUMENT MALFUNCTIONED, THERE WAS NO CONSEQUENCE TO THE PT. STAPLES WON'T CLOSE, LAS STAPLES WOULD NOT CLOSE DURING CO'S TEST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH ENDOSCOPIC ARTICULATING MULTIFEED STAPLER | ENDO STAPLER | GAG | ETHICON ENDO-SURGERY, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |