MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-06-21 for ENDO CLINCH II 174317 manufactured by Us Surgical Puerto Rico.
[111893606]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[111893607]
According to the reporter, during a laparoscopic procedure, the surgeon grasped the tissue with the device then when they tried to release the tissue the jaws would not release. The surgeon had to cut around the jaws to remove the instrument from the patient? S cavity.
Patient Sequence No: 1, Text Type: D, B5
[121648435]
Evaluation summary: post market vigilance (pmv) led an evaluation of one device. A visual inspection of the returned product noted: biological matter was present in the jaws of the device. Ratchet button had broken off from the body of the device. Ratchet button flange was not intact. Device jaws grasped and released properly when used concurrently with release lever as ratchet mechanism could not be deactivated due to disengaged ratchet button. 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 misuse of the product which caused or contributed to the reported condition. Replication of the broken ratchet switch may occur when improper or excessive force is exerted on the ratchet button. When the ratchet button not present on the handle the ratchet mechanism will be left activated, necessitating the use of the release lever in grasping and releasing the jaws. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647580-2018-03076 |
| MDR Report Key | 7625496 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-06-21 |
| Date of Report | 2018-09-24 |
| Date of Event | 2018-06-05 |
| Date Mfgr Received | 2018-09-01 |
| Date Added to Maude | 2018-06-21 |
| 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 | 2018-06-21 |
| Returned To Mfg | 2018-06-26 |
| Model Number | 174317 |
| Catalog Number | 174317 |
| Lot Number | P8B0726PX |
| 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 | 1. Required No Informationntervention | 2018-06-21 |