MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-10-31 for ENDO CLINCH* II 5MM INSTRUMENT 174317 manufactured by Covidien, Formerly Ussc Puerto Rico Inc.
[58747520]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[58747521]
According to the reporter, the device broke after the surgeon closed and opened the device a few times. Udi number is not available. The event occurred in use for patient. The procedure was completed with another device. The surgical time was not extended. The status of the patient: no problem. Additional tissue resection is not required. There was no tissue damage. The incision site was not extended. Nothing fell into the patient's cavity. The product did not lock on tissue and was removed from the tissue without damaging it. No bleeding occurred. Female patient the patient age is not available. The patient weight is not available. The device was not reprocessed/re-sterilized prior to use.
Patient Sequence No: 1, Text Type: D, B5
[62320869]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[71026711]
(b)(4). Evaluation summary: post market vigilance (pmv) concurrently with engineering led an evaluation of one device opened by the account and one photograph. The visual inspection of the device and photograph noted that the instrument was received broken in pieces. There was evidence of material transfer on both halves of the device. Replication of the observed damage may occur as a result of rough handling. Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647580-2016-00885 |
| MDR Report Key | 6066242 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-10-31 |
| Date of Report | 2016-10-04 |
| Date of Event | 2016-09-30 |
| Date Mfgr Received | 2017-02-22 |
| Date Added to Maude | 2016-10-31 |
| 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 | 3 |
| Brand Name | ENDO CLINCH* II 5MM INSTRUMENT |
| Generic Name | FORCEPS, OBSTETRICAL |
| Product Code | HAD |
| Date Received | 2016-10-31 |
| Returned To Mfg | 2016-11-16 |
| Model Number | 174317 |
| Catalog Number | 174317 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-10-31 |