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

Catalog Number 0029009

Device Problems Fire (1245); Smoking (1585); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the manufacturer for evaluation.An investigation of the device inspection records was conducted by the manufacturer.There were no deviations or non-conformances during the inspection process.Three (3) were received for evaluation.A visual inspection of one cable found damaged glass at the end of the cable.No physical damage or defect was found the other two (2) cables.Functional testing of two (2) cables found that the light output was very low and the two (2) "cable" were burning up.However, one cable was functioning properly without any defect or burning up when tested.The reported complaint is confirmed; one cable has broken/damaged glass and two cables were burning up and the light output was low.The dhr showed no manufacturing, workmanship, or material deficiency has been identified.The underlying root cause for the reported event is unknown.Device identifier (b)(4).

Event Description

A surgical sales specialist reported on behalf of the customer that a 0029009 assy cable ultralite 2 bifurc was burning.Additional information received on 18dec2018 indicating that there was smoke and fire noted.The product problem was discovered during an unspecified procedure.The action that was taken after the product problem occurred was that a new cable and light was used.The product was not in contact with the patient.No patient injury or death alleged, and the event did not lead to increase the surgery time.No other clinical information received.

• 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
• Manufacturer (Section G): INTEGRA YORK, PA INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 8208056
• MDR Text Key: 131778482
• Report Number: 2523190-2018-00192
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1