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

Catalog Number 001388LX9

Device Problems Fracture (1260); Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2018

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 biomed tech reported to integra that on (b)(6) 2018, during the setup for a case, the ul pro fused headlight cable 9ft, 275 cm become very dim while the surgeon was using the device for roughly 10 minutes.Upon further checking, the lightsource malfunctioned and become too hot, which burned and cracked the end of the lens of the cable.The patient was prepped for surgery, but the device was not in contact with the patient.There was no patient injury/death alleged, and no medical intervention was required.Initially it was reported of an unspecified delay in surgery due to product problem.Additional information was received on (b)(6) 2018, and reported that there was no delay in the procedure due to the product problem, and no patient impact.

Event Description

N/a.

Manufacturer Narrative

The product was not sent in to the manufacturer for evaluation.No failure analysis and determination of root cause could not be determined.The complaint could not be verified given that a product sample was not returned to verify the complaint.Udi #: (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: 8175605
• MDR Text Key: 130986210
• Report Number: 2523190-2018-00179
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 001388LX9
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1