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 2016-07-25 for ENDO CLINCH* II 5MM INSTRUMENT 174317 manufactured by Covidien, Formerly Ussc Puerto Rico Inc.
[50349400]
(b)(4). Patient information not provided. Udi not provided. Re-processing information not provided
Patient Sequence No: 1, Text Type: N, H10
[50349401]
According to the reporter, during a lobectomy, when lung parenchyma was set and released with the device, the root of jaws was broken. The device did not work. There were no operations which became a burden to the device. The procedure was completed with another device. The product was removed from the tissue without damaging it.
Patient Sequence No: 1, Text Type: D, B5
[50469048]
Patient Sequence No: 1, Text Type: N, H10
[51949856]
Patient Sequence No: 1, Text Type: N, H10
[63939413]
(b)(4). Post market vigilance (pmv) led an evaluation of one endo clinch. This 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 visual inspection of the device noted the jaws were broken. The shaft snapped just proximal to the jaws. Engineering found that the tube housing was broken on both tabs; jaws were still attached to the rivet of the broken tabs. The rivet was inspected and it was found properly riveted. Replication of the broken jaws may occur when excessive manipulation of side force (leverage) by user consequently causes the breakage of the tube housing tabs. The riveted tabs hold in place the jaws; once the tube housing is broken the jaws could become loose. The file will be closed as misuse of the product. Should new information become available, the file will be re-opened and reassessed at that time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647580-2016-00521 |
| MDR Report Key | 5820142 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-07-25 |
| Date of Report | 2016-07-05 |
| Date of Event | 2016-07-05 |
| Date Mfgr Received | 2016-12-09 |
| Device Manufacturer Date | 2015-11-01 |
| Date Added to Maude | 2016-07-25 |
| 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 | 2016-07-25 |
| Returned To Mfg | 2016-07-28 |
| Model Number | 174317 |
| Catalog Number | 174317 |
| Lot Number | P5L0024X |
| 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 | 2016-07-25 |