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 2017-02-27 for ENDO CLINCH* II 5MM INSTRUMENT 174317 manufactured by Covidien, Formerly Ussc Puerto Rico Inc.
[68413976]
(b)(4). Since the lot number was not provided, this information cannot be determined. Evaluation summary: post market vigilance (pmv) with engineering led an evaluation of one received one device opened by the account. The evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, an engineering evaluation, and an evaluation of the returned device. Engineering noted that the housing appeared to be partially split where the shaft meets the handle. The unit was disassembled for evaluation. Proper welding was observed: all energy directors were properly melted. Brownish particles were observed adhered to the center rod, which prevented the center rod to have a free movement transition during actuation. Thus affecting opening/closing of jaws during application. A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture. A review of the device history record could not be performed because the lot number was not provided. However, records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all medtronic quality release specifications at the time of manufacture. Replication of the reported condition may occur when some type of fluid solidifies inside the center rod thus causing the needle to get stuck during deployment. 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
[68413977]
According to the reporter, during surgery, the handle could not be squeezed anymore. The event occurred in use for patient. The procedure was completed with another device. The status of the patient: no problem. The patient gender is not available. 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
| Report Number | 2647580-2017-00190 |
| MDR Report Key | 6361212 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-27 |
| Date of Report | 2017-01-24 |
| Date of Event | 2016-08-08 |
| Date Mfgr Received | 2017-01-24 |
| Date Added to Maude | 2017-02-27 |
| 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 | 2017-02-27 |
| Returned To Mfg | 2016-10-12 |
| Model Number | 174317 |
| Catalog Number | 174317 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-02-27 |