MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2015-12-09 for ENDO CLINCH* II 5MM INSTRUMENT 174317 manufactured by Covidien, Formerly Ussc Puerto Rico Inc.
[33437607]
(b)(4). Additional attempts to obtain information and the device have been made. A supplemental report will be submitted with new details if they become available.
Patient Sequence No: 1, Text Type: N, H10
[33437608]
According to the reporter, the forceps broke when used by surgeon.
Patient Sequence No: 1, Text Type: D, B5
[33481077]
Patient Sequence No: 1, Text Type: N, H10
[33537800]
.
Patient Sequence No: 1, Text Type: N, H10
[33537801]
A portion of the device did fall into the patient cavity and were not retrieved from the patient.
Patient Sequence No: 1, Text Type: D, B5
[41754284]
Evaluation summary: post market vigilance (pmv) received one device opened by the account with the appropriate blister package in an undamaged condition. The evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, and an evaluation of the returned device. The jaws were found to be damaged. The rotation knob functioned properly. The jaws could not be operated and failed to open and close. The handles opened and closed without any hang ups noted. The unit was disassembled to evaluate the jaw subassembly, it was found the center rod broken. A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture. Subsequently, the complaint data did not display increased trends for the complaint. Replication of the observed conditions may occur due to excessive manipulation during application that consequently causes the breakage of the center rod. Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647580-2015-00881 |
| MDR Report Key | 5276788 |
| Report Source | FOREIGN |
| Date Received | 2015-12-09 |
| Date of Report | 2016-01-25 |
| Date of Event | 2015-12-02 |
| Date Mfgr Received | 2016-03-29 |
| Device Manufacturer Date | 2015-06-01 |
| Date Added to Maude | 2015-12-09 |
| 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 | 2015-12-09 |
| Returned To Mfg | 2016-01-25 |
| Model Number | 174317 |
| Catalog Number | 174317 |
| Lot Number | P5F0561X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-12-09 |