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

Catalog Number 600318

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Type  malfunction  

Manufacturer Narrative

On 6/8/17 integra investigation completed.Method: failure analysis, device history evaluation results: failure analysis - failure analysis cannot be completed due to the lack of information received to perform a complete investigation.Product has not been returned for evaluation.Unconfirmed/no return of device for evaluation.Device history evaluation - nonconforming product report / nonconforming material report history: none.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/corrections: none.Health hazard evaluation history: none.Conclusion: root cause cannot be determined due to the lack of information received to perform a complete investigation.Product has not been returned for evaluation.

Event Description

Customer initially reports the device has a defect at the distal end causing an arc.No harm to patient.

• 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: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6653627
• MDR Text Key: 78036630
• Report Number: 2523190-2017-00068
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 600318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2017
• 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