MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-04-19 for ENDO CLINCH II 174317 manufactured by Us Surgical Puerto Rico.
[106017215]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[106017216]
According to the reporter, following a coelio surgery, the patient was operated again by laparotomy and a piece of clamp was found during the exploration of the abdomen, but not the cause of the second operation.
Patient Sequence No: 1, Text Type: D, B5
[118550693]
Post market vigilance (pmv) led an evaluation of one device. Only broken jaw piece was returned. Jaw piece was broken between the jaw fulcrum and cable attachment point. A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture. Replication of the reported condition may occur when the device is exposed to a side force (leverage) that consequently breaks one side of the jaws. Another possibility is when the device is activated with too much force to the jaws and is used in a twisting motion resulting in breakage. The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647580-2018-01959 |
| MDR Report Key | 7445292 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-04-19 |
| Date of Report | 2018-06-27 |
| Date of Event | 2018-04-04 |
| Date Mfgr Received | 2018-06-12 |
| Date Added to Maude | 2018-04-19 |
| 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 | LISA HERNANDEZ |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | US SURGICAL PUERTO RICO |
| Manufacturer Street | 201 SABANETAS INDUSTRIAL PARK |
| Manufacturer City | PONCE PR 007164401 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 007164401 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDO CLINCH II |
| Generic Name | FORCEPS, OBSTETRICAL |
| Product Code | HDA |
| Date Received | 2018-04-19 |
| Returned To Mfg | 2018-04-18 |
| 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 | US SURGICAL PUERTO RICO |
| Manufacturer Address | 201 SABANETAS INDUSTRIAL PARK PONCE PR 007164401 US 007164401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-19 |