MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-11 for ASHA 4250-01 REP110847 manufactured by Medline Renewal.
[130183861]
It was reported that during a shoulder arthroscopy, the metal modes of the reprocessed arthrocare ambient? Super turbovac? Were noted to be missing. Reportedly, the surgical site was searched and the patient's shoulder was irrigated. A c-arm x-ray was reportedly used to confirm that no metal was retained in the shoulder. General anesthesia was used and there was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident. There was no serious injury or follow-up care reported related to this event. Due to the reported incident and in an abundance of caution, this medwatch is being filed. The sample is not available to be returned for evaluation. The lot number associated with the device was not reported. A review of the reprocessing record could not be performed. A root cause cannot be identified at this time. No additional information is available. If additional relevant information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[130183862]
It was reported that during a shoulder arthroscopy, metal modes of the reprocessed ambient? Super turbovac? Were noted to be missing requiring irrigation of the surgical site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032391-2018-00021 |
| MDR Report Key | 8150468 |
| Date Received | 2018-12-11 |
| Date of Report | 2018-12-11 |
| Date of Event | 2018-11-16 |
| Date Mfgr Received | 2018-11-20 |
| Date Added to Maude | 2018-12-11 |
| 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 | ARTHROCARE AMBIENT? SUPER TURBOVAC? 90? 90?SUCTION IFS 3.75 MM |
| Product Code | NUJ |
| Date Received | 2018-12-11 |
| Model Number | ASHA 4250-01 |
| Catalog Number | REP110847 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2018-12-11 |