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 2020-03-10 for ENDO CLINCH II 174317 manufactured by Us Surgical Puerto Rico.
[182740610]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182740611]
According to the reporter, during a laparoscopic colectomy, the two devices' jaws did not close and the ratchet lock broke. They changed to a new device to resolve the issue. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[186456829]
Evaluation summary: post market vigilance (pmv) led an evaluation of two devices. A visual inspection of the returned products noted that the ratchet switch was broken off on one of them. A functional evaluation found that the jaw rotation worked without difficulty on both devices. The jaw toggled and functioned without difficulty on both devices. Ratchet switch function would not lock into place on the broken 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 root cause of the observed damage was due to the product not being used as intended which caused or contributed to the reported condition. Replication of the reported condition may occur when improper or excessive force is exerted on the device. No further actions have been deemed necessary at this time. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647580-2020-00896 |
| MDR Report Key | 9811713 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-10 |
| Date of Report | 2020-04-02 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-03-18 |
| Date Added to Maude | 2020-03-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2020-03-10 |
| Returned To Mfg | 2020-03-09 |
| Model Number | 174317 |
| Catalog Number | 174317 |
| Lot Number | P9E1092Y |
| 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 | 2020-03-10 |