MAUDE Adverse Event Report: AESCULAP AG BIPOLAR COAGULATION FORCEPS0.4MMX120MM

Model Number GK690R

Device Problems Melted (1385); Overheating of Device (1437); Sparking (2595)

Patient Problems No Code Available (3191); Insufficient Information (4580)

Event Date 07/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with a bipolar coagulation forceps.According to the complaint description it was reported that during surgery the device sparked and melted.Surgical procedure: extra-cerebral blood vessel bypass.This incident did not cause an infection.Up to know the patient harm is unknown.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event/malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: visual investigation: the investigation was carried out visually and microscopically.The working ends are heavily burnt and melted at the points.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

Event Description

The adverse event / malfunction is filed under aag reference (b)(4).

• Brand Name: BIPOLAR COAGULATION FORCEPS0.4MMX120MM
• Type of Device: BIPOLAR COAGULATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10414766
• MDR Text Key: 203461492
• Report Number: 9610612-2020-00436
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• PMA/PMN Number: K770428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GK690R
• Device Catalogue Number: GK690R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other