MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-23 for PROXIMATE ILS CDH 25 manufactured by Ethicon.
[4052]
Intraluminal stapler did not fire staples into tissue because there were no staples in the device. Doctor used another stapling device to perform anastamosis. No injury to patient. Device labeled for single use. Patient medical status prior to event: satisfactory 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. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: yes. Corrective actions: device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8163 |
| MDR Report Key | 8163 |
| Date Received | 1993-07-23 |
| Date of Report | 1993-01-28 |
| Date of Event | 1993-01-15 |
| Date Facility Aware | 1993-01-15 |
| Report Date | 1993-01-28 |
| Date Reported to FDA | 1993-01-28 |
| Date Reported to Mfgr | 1993-01-15 |
| Date Added to Maude | 1994-07-26 |
| 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 | PROXIMATE ILS |
| Generic Name | INTRALUMINAL STAPLER |
| Product Code | FHM |
| Date Received | 1993-07-23 |
| Catalog Number | CDH 25 |
| Lot Number | DE28CMY |
| ID Number | CM00140445 |
| Device Expiration Date | 1997-07-01 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | 01-OCT-92 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 7838 |
| Manufacturer | ETHICON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-07-23 |