FDA Adverse Event
Malfunction
Summary report: N
AUTO SUTURE*PREMIUM SURGIPORT*10.5MM
MDR report key: 124105
·
Received September 30, 1997
Report
- Report Number
- 2647580-1997-01213
- Event Type
- Malfunction
- Date Received
- September 30, 1997
- Date of Event
- August 20, 1997
- Report Date
- September 5, 1997
- Manufacturer
- UNITED STATES SURGICAL CORPORATION
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
12/03/1997-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.
Description of Event or Problem · 1
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE SLEEVE WAS DAMAGED AND A COMPONENT DISENGAGED INTO THE PT'S CAVITY. THE SURGEON RETRIEVED THE COMPONENT WITHOUT PT'S INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTO SUTURE*PREMIUM SURGIPORT*10.5MM | DISPOSABLE SURGICAL TROCAR | GCJ | UNITED STATES SURGICAL CORPORATION | NA | P6F187 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |