MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-15 for ENDO CLINCH* II 5MM INSTRUMENT 174317 manufactured by Covidien, Formerly Ussc Puerto Rico Inc.
[25931656]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[25931657]
According to the reporter, during a gastric surgery there was an erroneous closing of jaws. Defective closing.
Patient Sequence No: 1, Text Type: D, B5
[26040726]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[26040727]
Additional information received by the account: the difficulty did not result in any tissue damage or patient injury. There was no unanticipated tissue loss. There was no unanticipated blood loss of 500cc or more. Surgery time was not delayed by more than 30 minutes. No device fragment fell into the patient. The patient was discharged. The jaws of the device did not close. The product was not re-sterilized before use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2647580-2015-00648 |
| MDR Report Key | 5077139 |
| Date Received | 2015-09-15 |
| Date of Report | 2015-09-16 |
| Date of Event | 2015-09-08 |
| Date Mfgr Received | 2015-09-08 |
| Device Manufacturer Date | 2015-01-01 |
| Date Added to Maude | 2015-09-15 |
| 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, FORMERLY USSC PUERTO RICO INC |
| Manufacturer Street | BUILDING 911-67 SABANETAS INDUSTRIAL PARK |
| Manufacturer City | PONCE PR 00731 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00731 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDO CLINCH* II 5MM INSTRUMENT |
| Generic Name | FORCEPS, OBSTETRICAL |
| Product Code | HAD |
| Date Received | 2015-09-15 |
| Model Number | 174317 |
| Catalog Number | 174317 |
| Lot Number | P5A0260X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN, FORMERLY USSC PUERTO RICO INC |
| Manufacturer Address | BUILDING 911-67 SABANETAS INDUSTRIAL PARK PONCE PR 00731 US 00731 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-15 |