MAUDE Adverse Event Report: INTEGRA YORK, PA INC. UL PRO FUSED HEADLIGHT CABLE 9FT, 275CM; CABLES

Catalog Number 001388LX9

Device Problem Temperature Problem (3022)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was not yet received by the manufacturer for evaluation.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A sales representative reported that the 001388lx9 ul pro fused headlight cable 9ft, the end of the plug was very hot to the touch after use.The cords were used at 80-100% power, above the recommendation.There was no patient contact and surgery delay reported.Additional information has been requested.

Manufacturer Narrative

Udi information: (b)(4).The device was returned for evaluation.No damage is visible on the cable.Integra's documentation states "do not place or rest a hot cable/metal end fitting or headlight on a patient or come into contact with unprotected skin until all components are cooled for at least 5 minutes.Failure to do so can result in burns and/or tissue damage." the cord's connector is also etched with the caution: hot / high temperature symbol.No manufacturing, workmanship, or material deficiency has been identified.

• Brand Name: UL PRO FUSED HEADLIGHT CABLE 9FT, 275CM
• Type of Device: CABLES
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• MDR Report Key: 8948165
• MDR Text Key: 193624047
• Report Number: 2523190-2019-00107
• Device Sequence Number: 1
• Product Code: FST
• Combination Product (y/n): N
• PMA/PMN Number: K864380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 001388LX9
• Device Lot Number: 10167516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Initial Date Manufacturer Received: 08/13/2019
• Initial Date FDA Received: 08/29/2019
• Supplement Dates Manufacturer Received: 09/09/2019
• Supplement Dates FDA Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1