MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-10-03 for PEAPOD FCPS 5-1/2 UP-ANG 2.3MM 280465 manufactured by Integra, York - Isurgical.
[18083452]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[18128096]
The customer medwatch# (b)(4) reports "the patient was in for a femoral rod. A peapod pituitary rongeur was broken in the wound; pieces were recovered. Micro pin holding the head of the pituitary rongeur was missing; pin was not found. This rongeur has been reprocessed. The number of times that this rongeur had been reprocessed is unknown. Device usage problem: malfunction-that is, the device did not do what it was supposed to do. " on (b)(6) 2011 e-mail from customer reports there was no patient harm. An x-ray was taken and no parts were found in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2011-00068 |
| MDR Report Key | 2369979 |
| Report Source | 06 |
| Date Received | 2011-10-03 |
| Date of Report | 2011-10-03 |
| Date Mfgr Received | 2011-09-12 |
| Date Added to Maude | 2012-06-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PEAPOD FCPS 5-1/2 UP-ANG 2.3MM |
| Generic Name | NA |
| Product Code | EIR |
| Date Received | 2011-10-03 |
| Catalog Number | 280465 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA, YORK - ISURGICAL |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-03 |