MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-03 for 279-351-100 REP106316 manufactured by Medline Renewal.
[113326367]
It was reported that during a right shoulder arthroscopy, the reprocessed serfas wand's tip broke off into the patient's shoulder. Per report, the wand became hot, a piece of the tip bubbled and then the tip flaked off into the patient's shoulder. The physician was reportedly able to locate the broken piece and successfully retrieve it from the patient. There was no serious injury reported related to the event. It was reported that the facility was able to grab another device and the surgery commenced without further incident. The reprocessed device was not returned for evaluation. A root cause could not be identified at this time. Due to reported incident and in an abundance of caution, medline renewal is filing this medwatch report. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[113326368]
It was reported that the reprocessed serfas wand's tip broke off into the patient's shoulder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032391-2018-00005 |
| MDR Report Key | 7660818 |
| Date Received | 2018-07-03 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-06-07 |
| Date Mfgr Received | 2018-06-07 |
| Device Manufacturer Date | 2018-05-02 |
| Date Added to Maude | 2018-07-03 |
| 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 | STEPHEN WILSON |
| Manufacturer Street | 1500 NE HEMLOCK AVE |
| Manufacturer City | REDMOND OR 97756 |
| Manufacturer Country | US |
| Manufacturer Postal | 97756 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | STRYKER SERFAS ENERGY 90-S, 90 DEGREE SUCTION PROBE, W/INTEGRATED CORD, (GREY) 3 |
| Product Code | NUJ |
| Date Received | 2018-07-03 |
| Returned To Mfg | 2018-10-02 |
| Model Number | 279-351-100 |
| Catalog Number | REP106316 |
| Lot Number | 386206 |
| Device Expiration Date | 2019-04-30 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE RENEWAL |
| Manufacturer Address | 1500 NE HEMLOCK AVE REDMOND OR 97756 US 97756 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-03 |