MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-14 for ENDO CLINCH* II 5MM INSTRUMENT 174317 manufactured by Covidien, Formerly Ussc Puerto Rico Inc.
[25929954]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[25929955]
According to the reporter, during a lap chole, the jaw of the endo clinch ii broke and became loose. The sample will not be returned because it was not decontaminated. No surgical time was extended and no harm to patient, no blood loss of more than 500cc. The doctor opened another endo clinch ii and continued with the procedure. No part of the device fell into the body cavity. The device was not reprocessed or re-sterilised prior to its usage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2647580-2015-00647 |
| MDR Report Key | 5075563 |
| Date Received | 2015-09-14 |
| Date of Report | 2015-09-07 |
| Date of Event | 2015-09-07 |
| Date Mfgr Received | 2015-09-07 |
| Device Manufacturer Date | 2014-12-01 |
| Date Added to Maude | 2015-09-14 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN, FORMERLY USSC PUERTO RICO INC |
| Manufacturer Street | BUILDING 911-67 SABANETAS INDUSTRIAL PARK |
| Manufacturer City | PONCE PR 00731 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00731 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ENDO CLINCH* II 5MM INSTRUMENT |
| Generic Name | FORCEPS, OBSTETRICAL |
| Product Code | HAD |
| Date Received | 2015-09-14 |
| Model Number | 174317 |
| Catalog Number | 174317 |
| Lot Number | P4M0166X |
| Device Expiration Date | 2019-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN, FORMERLY USSC PUERTO RICO INC |
| Manufacturer Address | BUILDING 911-67 SABANETAS INDUSTRIAL PARK PONCE PR 00731 US 00731 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-14 |