MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2017-01-11 for ENDO CLINCH* II 5MM INSTRUMENT 174317 manufactured by Covidien, Formerly Ussc Puerto Rico Inc.
[64586172]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[64586174]
According to the reporter, the jaw of the endoclinch broke off inside the patient after only a couple of minutes of usage. He said that it was a clean break and that he was 100% certain that they had retrieved the part that fell into the patient. The staff then opened a new one and continued the operation. There was no negative impact on the patient, no excessive time added to the operation and no blood loss or tissue damage.
Patient Sequence No: 1, Text Type: D, B5
[68039691]
(b)(4). Device has been received but evaluation not yet begun. A supplemental report will be sent upon completion of investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647580-2017-00032 |
| MDR Report Key | 6241058 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2017-01-11 |
| Date of Report | 2016-12-16 |
| Date of Event | 2016-12-02 |
| Date Mfgr Received | 2017-01-24 |
| Device Manufacturer Date | 2016-07-01 |
| Date Added to Maude | 2017-01-11 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 2034926373 |
| 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 | 3 |
| Brand Name | ENDO CLINCH* II 5MM INSTRUMENT |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY |
| Product Code | HAD |
| Date Received | 2017-01-11 |
| Returned To Mfg | 2017-01-24 |
| Model Number | 174317 |
| Catalog Number | 174317 |
| Lot Number | P6G0255PX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-01-11 |