MAUDE Adverse Event Report: INTEGRA YORK, PA INC. ASSY, CABLE ULTRALITE 2 BIFURC; N/A

Catalog Number 0029009

Device Problems Device Emits Odor (1425); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not yet 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.Linked to mfg report number: 2523190-2019-00041 and 2523190-2019-00042.

Event Description

This is 1 of 3 reports.A customer reported that the 0029009 assy, cable ultralite 2 bifurc was plugged into the 00mlx lightsource, within a minute, the entire cable was burned out and smoke was visible from the port.The patient was prepped for surgery.There was 10-15 minutes delay in surgery due to product problem.Additional information received on 26feb2019 and 27feb2019 stated that there was no smoke on the cable but the mlx unit smelled of smoke shortly after.The product problem occurred during a lumbar spine procedure.In addition, there was no patient adverse consequence due to delay.Additional information received on 06mar2019 indicated that the incident happened on (b)(6) 2019 during a laminectomy procedure.The patient was prepped for surgery with 2-3 minutes delay.There was no adverse consequences as a result of the delay.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, therefore the failure mode could not be confirmed.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: ASSY, CABLE ULTRALITE 2 BIFURC
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• MDR Report Key: 8432070
• MDR Text Key: 139202050
• Report Number: 2523190-2019-00040
• 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: 02/22/2019

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: 0029009
• Device Lot Number: 9708415
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2019
• Initial Date FDA Received: 03/19/2019
• Supplement Dates Manufacturer Received: 03/28/2019
• Supplement Dates FDA Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 00MLX 300W XENON LIGHTSOURCE.; 00MLX 300W XENON LIGHTSOURCE.