MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-11 for REPROCESSED ENDOPATH XCEL CB5LT manufactured by Stryker Sustainability Solutions, Inc..
[105184931]
Patient Sequence No: 1, Text Type: N, H10
[105184932]
A reprocessed 5mm trocar broke in half while inside of the patient during a laparoscopic cholecystectomy. No injury to the patient. The trocar broke in two between the hub and the tubing. All pieces of the device were accounted for. The device was given to risk management and it is still in my possession. I have taken a picture of the device for your review. (the device itself is available for return to the manufacturer. )
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7420863 |
| MDR Report Key | 7420863 |
| Date Received | 2018-04-11 |
| Date of Report | 2018-04-09 |
| Date of Event | 2018-02-28 |
| Report Date | 2018-04-09 |
| Date Reported to FDA | 2018-04-09 |
| Date Reported to Mfgr | 2018-04-09 |
| Date Added to Maude | 2018-04-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REPROCESSED ENDOPATH XCEL |
| Generic Name | LAPAROSCOPE, GENERAL PLASTIC SURGERY, REPROCESSED |
| Product Code | NLM |
| Date Received | 2018-04-11 |
| Catalog Number | CB5LT |
| Lot Number | 7134674 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SUSTAINABILITY SOLUTIONS, INC. |
| Manufacturer Address | 1810 W. DRAKE DR. TEMPE AZ 85283 US 85283 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-11 |