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 2016-12-21 for ENDO GRASP* 5MM INSTRUMENT 173030 manufactured by Covidien, Formerly Ussc Puerto Rico Inc.
[62918232]
(b)(4). Initial reporter phone number: (b)(6). Contact office phone number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[62918233]
According to the reporter, during a lap chole the handle just fell apart in the clinician? S hand.
Patient Sequence No: 1, Text Type: D, B5
[66900410]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647580-2016-01130 |
| MDR Report Key | 6192711 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2016-12-21 |
| Date of Report | 2016-11-29 |
| Date of Event | 2016-11-29 |
| Date Mfgr Received | 2017-01-10 |
| Device Manufacturer Date | 2016-05-01 |
| Date Added to Maude | 2016-12-21 |
| 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 |
| 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 | 2016-12-21 |
| Returned To Mfg | 2017-01-10 |
| Model Number | 173030 |
| Catalog Number | 173030 |
| Lot Number | P6E0320X |
| 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 | 2016-12-21 |