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 2016-04-18 for ENDO CLINCH* II 5MM INSTRUMENT 174317 manufactured by Covidien, Formerly Ussc Puerto Rico Inc.
[42918343]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[42918344]
According to the reporter, during a laparoscopic endometrial cancer extirpation, upon clamping fat of mesentery, the jaws fixed in the closing position, and did not open. Fat was resected to remove the device from the 5 mm port. No patient harm and tissue damage has been reported since the resected tissue was fat.
Patient Sequence No: 1, Text Type: D, B5
[42963125]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[45401252]
Patient Sequence No: 1, Text Type: N, H10
[49577179]
Evaluation summary: post market vigilance (pmv) led an evaluation 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 ratchet switch was disengaged. The rotation knob functioned without difficulty. The jaws were opened and closed, and grasped media without difficulty. A review of the device history record could not be performed because the lot number was not provided. However, records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. Replication of the secondary blades indicates that the instrument may have been exposed to an external force which bent the exposed metal bars. 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 | 2647580-2016-00168 |
| MDR Report Key | 5585054 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-04-18 |
| Date of Report | 2016-04-07 |
| Date of Event | 2016-03-03 |
| Date Mfgr Received | 2016-07-13 |
| Date Added to Maude | 2016-04-18 |
| 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 | 2016-04-18 |
| Returned To Mfg | 2016-05-04 |
| Model Number | 174317 |
| Catalog Number | 174317 |
| 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 | 2016-04-18 |