MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-19 for AUTO SUTURE 83421-06 178021 manufactured by United States Surgcal Corp..
[18142556]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3509 |
| MDR Report Key | 3509 |
| Date Received | 1993-01-19 |
| Date of Report | 1992-08-28 |
| Date of Event | 1992-08-24 |
| Date Facility Aware | 1992-08-24 |
| Report Date | 1992-08-28 |
| Date Reported to Mfgr | 1992-08-24 |
| Date Added to Maude | 1993-04-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTO SUTURE |
| Generic Name | ECIO M6 ACC. KIT |
| Product Code | KYP |
| Date Received | 1993-01-19 |
| Model Number | 83421-06 |
| Catalog Number | 178021 |
| Lot Number | NIJ86M 10/96 |
| Device Expiration Date | 1996-10-01 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 3251 |
| Manufacturer | UNITED STATES SURGCAL CORP. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-01-19 |