FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH DISPOSABLE SURGICAL TROCAR
MDR report key: 82097
·
Received February 19, 1997
Report
- Report Number
- 1527736-1997-00172
- Event Type
- Malfunction
- Date Received
- February 19, 1997
- Report Date
- February 19, 1997
- Manufacturer
- EES-JUAREZ
- Product Code
- GCJ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS OF EVALUATION: CONCLUSION: BASED ON THE VISUAL EXAMINATION AND THE FUNCTIONAL TESTING THE FAILURE TO ARM WAS CONFIRMED. TESTING INDICATES FRACTURING AND A SKEWNESS OF THE KNIFE COLLAR.
Description of Event or Problem · 1
DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE 511S TROCAR WOULD NOT ARM CORRECTLY. THERE WAS NO CONSEQUENCE TO THE PT. 1/27/97 THE CASE WAS COMPLETED WITH ANOTHER 511S. CLINICAL FOLLOW UP: 1/29/97 1353 CONTACT PERSON STATED NO ADD'L INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH DISPOSABLE SURGICAL TROCAR | TROCAR | GCJ | EES-JUAREZ | NA | J45E6T |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |