MAUDE Adverse Event Report: INTEGRA YORK, PA INC. MONOPOLAR CABLE 10 FEET; ELECTROSURGICAL COAGULATION

Catalog Number 600290

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Type  malfunction  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

Customer initially reports one of the wires inside broke and caused an arc, which split open and broke in half during a case.(b)(6) 15 customer reports doctor was performing a laparoscopic cholecystectomy that was connected to a jarit j-hook 5mm 32cm #600-319; and a valleylab force electrocautery unit #(b)(4).Event occurred immediately upon use of cautery.No harm done, no further information available.

Manufacturer Narrative

On 3/21/2016 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - monopolar cable was returned in used condition, not showing any unusual markings, with scratches and showing wear.It is noticed the one end has broken off.There appears to be evidence of melting/fire to the cord.The findings are, "the plug is broken at the back of the protective rubber sleeve.There are burn marks visible.The cable coating shows a kink next to the breakpoint.After removing the insulation a strong oxidized litz wire is/was visible.The litz wire is without kevlar, this implies that it is old.The litz wire is strong lengthened at the breakpoint.This indicates common kink.The strong oxidation indicates that the litz wire was cleaned and prepared incorrectly.The oxidation affects the whole wire." device history evaluation - dhr review was completed with all history available.Nonconforming product report / nonconforming material report history: there is no applicable nonconforming product report / nonconforming material report history.Variance authorization / deviation history: none.Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history.Corrective action preventive action history: previously issued for cable damage resulting in fire or a potential to start a fire.Health hazard evaluation history: previously issued for cable damage leading to a safety hazard is identified in risk management files as a potential source of fire and user / patient harm.The complaint report has been confirmed.Conclusion: the root cause has not been identified as a workmanship or material deficiency.

• Brand Name: MONOPOLAR CABLE 10 FEET
• Type of Device: ELECTROSURGICAL COAGULATION
• 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: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5226331
• MDR Text Key: 31332244
• Report Number: 2523190-2015-00126
• Device Sequence Number: 1
• Product Code: KNF
• Combination Product (y/n): N
• PMA/PMN Number: K932456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 600290
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• 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