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 2018-05-24 for ENDO CLINCH II 174317 manufactured by Us Surgical Puerto Rico.
[109225450]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[109225451]
According to the reporter, during a laparoscopic low anterior resection procedure, while grasping and manipulating the bowel, the tip of the device was broken. Another device was used to complete the case. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[126163989]
Evaluation summary: post market vigilance (pmv) led an evaluation of one device. The visual inspection of the returned product noted: shaft fork where jaw attaches was bent and deformed. One side of jaw had disengaged from device. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition; therefore, a review of the device history record was not performed. The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition. Replication of the reported condition may occur when the device is exposed to a side force (leverage) that consequently bends or breaks shaft fork where jaw attaches. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647580-2018-02693 |
| MDR Report Key | 7542809 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-24 |
| Date of Report | 2018-11-02 |
| Date of Event | 2018-05-17 |
| Date Mfgr Received | 2018-10-09 |
| Device Manufacturer Date | 2017-07-10 |
| Date Added to Maude | 2018-05-24 |
| 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 | 2018-05-24 |
| Returned To Mfg | 2018-08-30 |
| Model Number | 174317 |
| Catalog Number | 174317 |
| Lot Number | P7G0612PX |
| 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 | 2018-05-24 |