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

Catalog Number 600290

Device Problem Fire (1245)

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

Event Date 10/21/2016

Event Type  malfunction  

Manufacturer Narrative

Integra has completed their internal investigation on november 10, 2016.The investigation included: methods: review of device history records, review of complaints history.Results: dhr review; nonconforming product report / nonconforming material report history: none.Complaints history; complaint metrics tracked, trended, and reviewed monthly with management.Conclusion: root cause cannot be determined due to the lack of information received to perform a complete investigation.Instrument was not returned.

Event Description

Customer initially reports the cable failed and caught fire during a case.Cable was plugged into covidian force fx customer says cable is likely over 5 years old.On 11/1/2016 customer reports a laparoscopic ventral hernia repair was being performed.No patient harm.Replacement equipment available.

• 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: 6112461
• MDR Text Key: 60312335
• Report Number: 2523190-2016-00187
• Device Sequence Number: 1
• Product Code: KNF
• Combination Product (y/n): N
• PMA/PMN Number: K103726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: COVIDIAN FORCE FX
• Patient Age: 74 YR