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.
[130487607]
The event was reported to key surgical by (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 events leading up to the described event, but was able to confirm part number, lot number and device description information. The cause of the reported malfunction/adverse event is unknown. The lot history information including device history records, inspection records and requests for information on supplier manufacturing information for the reported lot 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 the light handle cover t is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[130487608]
Surgical light handle cover placed over light handle prior to surgical start. Intraoperatively, the surgeon reached for the light to change the angle. The light handle cover split and fell into the surgical field. The user facility reported that the patient was treated with antibiotics postoperatively. No other patient impact was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183785-2018-00002 |
| MDR Report Key | 8166241 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-12-14 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-10-22 |
| Date Mfgr Received | 2018-11-15 |
| Device Manufacturer Date | 2018-04-04 |
| 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 | 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 | 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 | 64055 |
| 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 |