MAUDE Adverse Event Report: KEY SURGICAL LLC KEY SURGICAL UNIVERSAL LIGHT HANDLE COVER

Model Number	LHC-201-160
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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%.
Event or Problem Description
Dark blue soft plastic portion of the light handle cover separated from light blue hard plastic base.No patient impact reported.

• Brand Name: KEY SURGICAL UNIVERSAL LIGHT HANDLE COVER
• Common Device Name: LIGHT HANDLE COVER
• Manufacturer (Section D): KEY SURGICAL LLC; 8101 wallace road; eden prairie MN 55344
• MDR Report Key: 8166036
• Report Number: 2183785-2018-00003
• Device Sequence Number: 2792422
• Product Code: FTA
• UDI-Device Identifier: 00849771030591
• UDI-Public: 00849771030591
• Combination Product (Y/N): N
• PMA/510(K) Number: K150532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LHC-201-160
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization