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 2019-01-03 for ENDO CLINCH II 174317 manufactured by Us Surgical Puerto Rico.
[131917809]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[131917810]
According to the reporter, while being applied on dissection during a laparoscopic sleeve gastrectomy, the devices did not grasp properly, and the jaws were broken. They used another device to complete the case. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2647580-2019-00038 |
MDR Report Key | 8212362 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2019-01-03 |
Date of Report | 2019-03-14 |
Date of Event | 2018-01-29 |
Date Mfgr Received | 2019-02-19 |
Device Manufacturer Date | 2017-12-29 |
Date Added to Maude | 2019-01-03 |
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 | 2019-01-03 |
Model Number | 174317 |
Catalog Number | 174317 |
Lot Number | P7M1479PX |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | * |
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 | 2019-01-03 |