MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-13 for ENDO GRASP* 5MM INSTRUMENT 173030 manufactured by Covidien, Formerly Ussc Puerto Rico Inc.
[31365771]
Evaluation summary: post market vigilance (pmv) led an evaluation received 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 review of the product, and an evaluation of the returned device. Unit was received dismantled with missing components; only the tube housing assembly, trigger release, trigger and cover were received. Good welding was observed on cover. Unit condition precludes any functional verification. A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture. There were no adverse patient events reported as a result of the alleged event. Should new information become available, the file will be re-opened and reassessed at that time. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[31365772]
According to the reporter, the device opened (dismantled) entirely in surgeon's hands. They'd to open another unit to finish the procedure. There was no injury to the patient, since this didn't happened during the application.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2647580-2015-00796 |
| MDR Report Key | 5221291 |
| Date Received | 2015-11-13 |
| Date of Report | 2015-11-12 |
| Date Mfgr Received | 2015-11-12 |
| Device Manufacturer Date | 2008-06-01 |
| Date Added to Maude | 2015-11-13 |
| 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 | 0 |
| Brand Name | ENDO GRASP* 5MM INSTRUMENT |
| Generic Name | FORCEPS, OBSTETRICAL |
| Product Code | HAD |
| Date Received | 2015-11-13 |
| Returned To Mfg | 2015-09-21 |
| Model Number | 173030 |
| Catalog Number | 173030 |
| Lot Number | P8F0287 |
| Device Expiration Date | 2013-06-30 |
| 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 | 2015-11-13 |