MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-11-20 for FORCEPS MCL-S21 RIGHT SATALOFF HEART manufactured by Integra York, Pa Inc..
[92549101]
Integra has completed their internal investigation on november 15, 2017. Results: evaluation of returned device; during the analysis of the returned used forceps, it is noticed that the tips is broken, without knowing how the instrument was used during use, the cause is undetermined. The complaint report is confirmed; damaged worn. Dhr review: no anomalies that could be associated with the complaint were observed. Complaints history: no adverse trend - first occurrence of this risk for this device. Conclusion: there were forceps, returned used/processed, showing wear and a broken tip. The complaint report has been confirmed. The root cause has not been identified as a workmanship or material deficiency.
Patient Sequence No: 1, Text Type: N, H10
[92549104]
It was reported that the tip of the instrument broke in patient's airway during surgical procedure. Surgeon was able to retrieve the broken piece. Patient injury was reported and medical intervention was required. The event lead to surgical delay, it is unknown for how long. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2017-00145 |
| MDR Report Key | 7046122 |
| Report Source | USER FACILITY |
| Date Received | 2017-11-20 |
| Date of Report | 2017-10-26 |
| Date of Event | 2017-10-26 |
| Date Mfgr Received | 2017-10-26 |
| Date Added to Maude | 2017-11-20 |
| 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 | USER SONIA IRIZARRY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FORCEPS MCL-S21 RIGHT SATALOFF HEART |
| Generic Name | PFM11 |
| Product Code | KAE |
| Date Received | 2017-11-20 |
| Returned To Mfg | 2017-11-07 |
| Catalog Number | MCL-S21 |
| Lot Number | 140901 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-20 |