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

Catalog Number 600318

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.Linked to mfg report number : 23190-2019-00121.

Event Description

1 of 2 reports.A customer reported to integra that on (b)(6) 2019, a 600318 l-shape hook electrode 5mm32cm used for laparoscopy procedures, the insulation was coming off after first use.There was no patient injury or death alleged.It is unknown if there was patient contact or surgical delay.Request for additional information has been sent.

Manufacturer Narrative

Udi information: (b)(4).The product was returned for evaluation.The lot number / serial number not received to perform device history record review.The l shape of the electrode hook, the insulation was coming off.This type of damage is from use and handling.There was no repair marking indicating that preventive maintenance was performed.The complaint report is confirmed: damage/worn.The root cause has not been identified as a workmanship or material deficiency.

Event Description

N/a.

• 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
• MDR Report Key: 9191166
• MDR Text Key: 194777176
• Report Number: 2523190-2019-00120
• 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
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1