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 2016-06-13 for ENDO GRASP* 5MM INSTRUMENT 173030 manufactured by Covidien, Formerly Ussc Puerto Rico Inc.
[47227969]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[47227970]
According to the reporter, during a myomectomy, one sheet of the jaw of the instrument was broken. One piece of the jaw fall into the cavity, the doctor use another endo grasp to retrieve the piece of the jaw.
Patient Sequence No: 1, Text Type: D, B5
[51351985]
Patient Sequence No: 1, Text Type: N, H10
[61916844]
(b)(4). Post market vigilance (pmv)and engineering led an evaluation of one device opened by the account. This 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. One of the jaws was disengaged from the device. A review of the device history record indicates this device lot number was released meeting all medtronic quality release specifications at the time of manufacture. Replication of damaged disengaged jaw condition may occur due to extreme handling during the application, as when too much force and excessive leverage is applied. Based on the product analysis, the failure was confirmed to be attributed to the reported event. 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 | 2647580-2016-00317 |
| MDR Report Key | 5720257 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2016-06-13 |
| Date of Report | 2016-06-02 |
| Date of Event | 2016-06-01 |
| Date Mfgr Received | 2016-11-11 |
| Device Manufacturer Date | 2015-03-01 |
| Date Added to Maude | 2016-06-13 |
| 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 GRASP* 5MM INSTRUMENT |
| Generic Name | FORCEPS, OBSTETRICAL |
| Product Code | HAD |
| Date Received | 2016-06-13 |
| Returned To Mfg | 2016-07-25 |
| Model Number | 173030 |
| Catalog Number | 173030 |
| Lot Number | P5C1051X |
| 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 | 2016-06-13 |