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

Model Number LHC-201-160

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 10/22/2018

Event Type  malfunction  

Manufacturer Narrative

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).

Event Description

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.

• Brand Name: KEY SURGICAL UNIVERSAL LIGHT HANDLE COVER
• Type of Device: LIGHT HANDLE COVER
• Manufacturer (Section D): KEY SURGICAL LLC; 8101 wallace road; eden prairie MN 55344
• Manufacturer (Section G): KEY SURGICAL LLC; 8101 wallace road; eden prairie MN 55344
• Manufacturer Contact: jake schultz ; 8101 wallace road; eden prairie, MN 55344 ; 8005417995
• MDR Report Key: 8166241
• MDR Text Key: 130487607
• Report Number: 2183785-2018-00002
• Device Sequence Number: 1
• Product Code: FTA
• UDI-Device Identifier: 00849771030591
• UDI-Public: 00849771030591
• Combination Product (y/n): N
• PMA/PMN Number: K150532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2023
• Device Model Number: LHC-201-160
• Device Lot Number: 64055
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization