MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-12-14 for KEY SURGICAL UNIVERSAL LIGHT HANDLE COVER LHC-201-160 manufactured by Key Surgical Llc.
[130489206]
The event was reported to key surgical by a (b)(4) distributor of the device, (b)(4). The reported event occurred in (b)(6); however, key surgical has historically marketed similar versions of the device in the united states using the same part number. The device was unavailable for investigation. Key surgical, together with (b)(4) requested additional information from the hospital facility that initially reported the complaint information to the distributor, (b)(4) on several separate dates. The user facility was unable to provide further information on the reported event. The cause of the reported malfunction is unknown. The review of the limited information available for the device complaint received from (b)(4) and the user facility resulted in no non-conformities, abnormalities or information related to the complaint root cause. Through 12/12/2018, review of complaint history against sales data reveals that the complaint rate for this product is 0. 68%.
Patient Sequence No: 1, Text Type: N, H10
[130489207]
Dark blue soft plastic portion of the light handle cover separated from light blue hard plastic base. No patient impact reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183785-2018-00003 |
| MDR Report Key | 8166036 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-12-14 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-10-29 |
| Date Mfgr Received | 2018-11-15 |
| Date Added to Maude | 2018-12-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | JAKE SCHULTZ |
| Manufacturer Street | 8101 WALLACE ROAD |
| Manufacturer City | EDEN PRAIRIE MN 55344 |
| Manufacturer Country | US |
| Manufacturer Postal | 55344 |
| Manufacturer Phone | 8005417995 |
| Manufacturer G1 | KEY SURGICAL LLC |
| Manufacturer Street | 8101 WALLACE ROAD |
| Manufacturer City | EDEN PRAIRIE MN 55344 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55344 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KEY SURGICAL UNIVERSAL LIGHT HANDLE COVER |
| Generic Name | LIGHT HANDLE COVER |
| Product Code | FTA |
| Date Received | 2018-12-14 |
| Model Number | LHC-201-160 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KEY SURGICAL LLC |
| Manufacturer Address | 8101 WALLACE ROAD EDEN PRAIRIE MN 55344 US 55344 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-12-14 |