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 Date 06/26/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A customer reported that on (b)(6) 2019, the 001388lx9 ul pro fused headlight cable 9ft, 275cm, the end of the plugs, which connects into the lightsource, becomes very hot to the touch after its use.There was no patient contact, and no surgical delay reported.Request for additional information has been sent.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, therefore the failure mode cannot be confirmed.Device history record review unavailable for serial number (b)(4).A failure analysis and determination of root cause is not possible due to the lack of information received to perform a complete investigation.Product has not been returned.The reported complaint is unconfirmed.Device identifier: (b)(4).

• 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: 8811870
• MDR Text Key: 151741649
• Report Number: 2523190-2019-00095
• 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: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• 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?: No
• Date Manufacturer Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIGHTSOURCE; LIGHTSOURCE