MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-12 for ENDO CLINCH* II 5MM INSTRUMENT 174317 manufactured by Covidien, Formerly Ussc Puerto Rico Inc.
[28039211]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[28039212]
According to the reporter, during a lap. Excision of lesion of uterus. , the tip of the device was broken during grasping tissue, a pin came off. Nothing fell into the cavity. No foreign piece was found inside patient according to x ray. Operating time extended less than 30 min. No additional tissue resection. Not issue damage or bleeding. Nothing fell into the cavity. No patient harm. Patient age, gender: not provided
Patient Sequence No: 1, Text Type: D, B5
[44135148]
Post market vigilance (pmv) led an evaluation of one device opened by the account. 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, an engineering evaluation, and an evaluation of the returned device. The unit was received un-riveted, the rivet was not received. The unit has evidence that it was riveted. Tube housing was observed bowed and its distal end legs wide open. A damage/scratch was observed on both side of the distal shaft. 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 leverage during the application that causes a bow in the tube and the opening of the distal end legs, thus overcoming the riveting flare causing the rivet to fall out. 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 | 2647580-2015-00726 |
| MDR Report Key | 5144598 |
| Date Received | 2015-10-12 |
| Date of Report | 2015-11-13 |
| Date of Event | 2015-10-01 |
| Date Mfgr Received | 2016-04-29 |
| Device Manufacturer Date | 2015-05-01 |
| Date Added to Maude | 2015-10-12 |
| 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 | 2015-10-12 |
| Returned To Mfg | 2015-11-13 |
| Model Number | 174317 |
| Catalog Number | 174317 |
| Lot Number | P5E0102X |
| 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 | 1. Required No Informationntervention | 2015-10-12 |