MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-10 for ENDO CLINCH* II 5MM INSTRUMENT 174317 manufactured by Covidien, Formerly Ussc Puerto Rico Inc.
[31108128]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[31108129]
According to the reporter, during a laparoscopic cholecystectomy, when the surgeon attempted to grasp the gallbladder, the jaws were broken. New one was opened to correct the problem. Gender: not available. Age and weight: not available. Last patient's status: good. Operating time not extended. Additional tissue resection: no. Tissue damage: no. Nothing fell into the cavity. Oozing bleeding.
Patient Sequence No: 1, Text Type: D, B5
[35033113]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[41320968]
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, a pmv review of complaint trends, an engineering review and an evaluation of the returned device. Damaged jaws were observed. The jaws failed to close completely and one jaw was loose. The rotation knob functioned properly. The handles opened and closed without any hang ups noted. The jaws could not be operated properly. The jaws failed to close completely. Engineering concluded that concluded that the root cause for the reported defect was the use of excessive manipulation during application that consequently caused the breakage of the tube housing tabs. The received unit is consistent with a unit that was extremely manipulated during application, using the device as a lever increasing the stress force on the tabs of the tube. A review of the device history record indicates this device lot number was released meeting all medtronic quality release specifications at the time of manufacture. Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647580-2015-00788 |
| MDR Report Key | 5213263 |
| Date Received | 2015-11-10 |
| Date of Report | 2015-12-09 |
| Date of Event | 2015-11-02 |
| Date Mfgr Received | 2016-03-18 |
| Device Manufacturer Date | 2015-04-30 |
| Date Added to Maude | 2015-11-10 |
| 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 | 2015-11-10 |
| Returned To Mfg | 2015-12-09 |
| Model Number | 174317 |
| Catalog Number | 174317 |
| Lot Number | P5D0221X |
| 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 | 2015-11-10 |