MAUDE Adverse Event Report: INTEGRA YORK, PA INC. L-SHAPE HOOK ELECTRODE 5MM32CM; ELECTROSURGICAL COAGULATION

Catalog Number 600318

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

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

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, therefore the failure mode cannot be confirmed.Lot number / serial number was not received to perform device history record review.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).Linked to mfg report number: 2523190-2019-00078.

Event Description

1 of 2 reports.A customer reported that there was a fire in a hydrogen peroxide sterilizer.The device 600318 l-shape hook electrode was mentioned in the event.The fire was contained, and the humidity was maintained.It was unknown if there were any injuries.Request for additional information has been sent.

• Brand Name: L-SHAPE HOOK ELECTRODE 5MM32CM
• 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: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 8678638
• MDR Text Key: 147325533
• Report Number: 2523190-2019-00077
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 600318
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2019
• 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: (B)(4) HOOK ELECTRODE