MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-09 for ENDO GRASP* 5MM INSTRUMENT 173030 manufactured by Covidien, Formerly Ussc Puerto Rico Inc.
[31080594]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[31080595]
According to the reporter, during a lap. Excision of lesion of uterus. Upon trying to insert the device into a trocar, the tip of the shaft broke. Used another device to complete the procedure. Operating time not extended. Additional tissue resection: no. Tissue damage: no. Nothing fell into the cavity. No bleeding.
Patient Sequence No: 1, Text Type: D, B5
[34488527]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[40180432]
Evaluation summary: 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, an engineering review, a pmv review of complaint trends, and an evaluation of the returned device. The device was received with a broken jaw. No functional testing could be performed due to the damages. A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture. Engineering concluded that the root cause for the reported defect was the use of excessive manipulation by user that consequently caused the breakage of the tube housing tabs. The received unit is consistent with a unit that was manipulated with excessive force during procedure by user, using the device as a lever increasing the stress force on the tabs of the tube. Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647580-2015-00787 |
| MDR Report Key | 5210970 |
| Date Received | 2015-11-09 |
| Date of Report | 2015-12-08 |
| Date of Event | 2015-10-28 |
| Date Mfgr Received | 2016-03-09 |
| Date Added to Maude | 2015-11-09 |
| 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 GRASP* 5MM INSTRUMENT |
| Generic Name | FORCEPS, OBSTETRICAL |
| Product Code | HAD |
| Date Received | 2015-11-09 |
| Returned To Mfg | 2015-12-08 |
| Model Number | 173030 |
| Catalog Number | 173030 |
| 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 | 2015-11-09 |