FDA Adverse Event
Malfunction
Summary report: N
AUTO SUTURE
MDR report key: 3509
·
Received January 19, 1993
Report
- Report Number
- 3509
- Event Type
- Malfunction
- Date Received
- January 19, 1993
- Date of Event
- August 24, 1992
- Report Date
- August 28, 1992
- Manufacturer
- UNITED STATES SURGCAL CORP.
- Product Code
- KYP
- Product Problem
- Yes
- Report Source
- User Facility report
Narratives
Description of Event or Problem · 1
TROCAR - PIECE OF INSTRUMENT SEPERATED PLUS CO2 WAS LEAKINGDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTO SUTURE | ECIO M6 ACC. KIT | KYP | UNITED STATES SURGCAL CORP. | 83421-06 | NIJ86M 10/96 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Other |