MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-22 for 2.0 CHOMIC SUTURE NEEDLE G-123H manufactured by Ethicon Inc..
[3745]
During suturing procedure physician noticed tip of needle missing. The surgical wound, sterile field, and surrounding area were searched, but tip was not found. Post-op x-rays were negative. Needle product was impounded and sent to csp. Sales representative is to pick up the week of april 12. Device labeled for single use. Patient medical status prior to event: fair condition. 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 not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service, device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6801 |
| MDR Report Key | 6801 |
| Date Received | 1993-07-22 |
| Date of Report | 1993-04-14 |
| Date of Event | 1993-04-07 |
| Date Facility Aware | 1993-04-07 |
| Report Date | 1993-04-14 |
| Date Reported to Mfgr | 1993-04-12 |
| Date Added to Maude | 1993-10-15 |
| 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 | 2.0 CHOMIC SUTURE NEEDLE |
| Product Code | HAS |
| Date Received | 1993-07-22 |
| Model Number | G-123H |
| Lot Number | DJR366D |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | 01-APR-93 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 6484 |
| Manufacturer | ETHICON INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-07-22 |