MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-21 for ENDO GIA UNK-EGIAADAPTER manufactured by Covidien Lp Llc North Haven.
[93051737]
Evaluation summary: to date, the incident sample has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[93051738]
According to the reporter: occurred during a single vats lobectomy procedure. The stapler was unable to fire. The surgeon could press the green firing button but could not squeeze the handle. The side of the reload broke off but did not fall into the patient cavity. A new device was used in order to resolve the issue. No information was provided regarding impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2017-08974 |
| MDR Report Key | 7048434 |
| Date Received | 2017-11-21 |
| Date of Report | 2017-11-21 |
| Date of Event | 2017-11-01 |
| Date Mfgr Received | 2017-11-01 |
| Date Added to Maude | 2017-11-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN LP LLC NORTH HAVEN |
| Manufacturer Street | 195 MCDERMOTT RD |
| Manufacturer City | NORTH HAVEN 06473 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06473 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ENDO GIA |
| Generic Name | TEST, LEUKOCYTE PEROXIDASE |
| Product Code | GIA |
| Date Received | 2017-11-21 |
| Model Number | UNK-EGIAADAPTER |
| Catalog Number | UNK-EGIAADAPTER |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP LLC NORTH HAVEN |
| Manufacturer Address | 195 MCDERMOTT RD NORTH HAVEN 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-21 |