MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-06-21 for ENDO CLINCH* II 5MM INSTRUMENT 174317 manufactured by Covidien, Formerly Ussc Puerto Rico Inc.
[47840605]
Manufacturer reference number: (b)(4). Udi not provided. Re-processing information not provided.
Patient Sequence No: 1, Text Type: N, H10
[47840606]
According to the reporter, during a colectomy procedure, the tip of the jaws disengaged. No injury at patient. The device was discarded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2647580-2016-00338 |
| MDR Report Key | 5738601 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-06-21 |
| Date of Report | 2016-06-15 |
| Date of Event | 2016-06-15 |
| Date Mfgr Received | 2016-06-15 |
| Device Manufacturer Date | 2015-10-01 |
| Date Added to Maude | 2016-06-21 |
| 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, 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 | 2016-06-21 |
| Model Number | 174317 |
| Catalog Number | 174317 |
| Lot Number | P5K0382X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2016-06-21 |