MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-04 for ETHICON ER 320 ER 340 manufactured by Johnson & Johnson.
[4004]
Ethicon er 320 stapler was misfiring. Stales would not close or would not meet at points. Staff had to open new er 320 to staple and completed procedure without complication. Device not 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 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: use of all similar devices stopped temporarily. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7793 |
| MDR Report Key | 7793 |
| Date Received | 1994-02-04 |
| Date of Report | 1993-09-24 |
| Date of Event | 1993-09-17 |
| Date Facility Aware | 1993-09-20 |
| Report Date | 1993-09-24 |
| Date Reported to Mfgr | 1993-09-21 |
| Date Added to Maude | 1994-05-19 |
| 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 | ETHICON |
| Generic Name | ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER |
| Product Code | HBS |
| Date Received | 1994-02-04 |
| Model Number | ER 320 |
| Catalog Number | ER 340 |
| Lot Number | EJ5183Y |
| Device Expiration Date | 1998-07-01 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | 01-SEP-93 |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 7472 |
| Manufacturer | JOHNSON & JOHNSON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-02-04 |