MAUDE Adverse Event Report: AESCULAP AG CASPAR BIPOLAR FORCEPS 2.0X125/220MM; BIPOLAR COAGULATION

Model Number GK980R

Device Problem Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: 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 bipolar forceps.Additional information provided, that at first it was reported as a possible burn on the surgeon's hand, but when talking to the nurse, it was confirmed that there was no burn.The device created sparks and "burned" the surface of the tweezers; smoke was visible and exerting strong heat in the hand of the surgeon.There was no patient harm and forceps were promptly replaced and the surgery continued normally.This malfunction did not prolonged the surgery.Additional patient information is not available.(b)(4).

Manufacturer Narrative

Investigation results: the device was not provided for investigation.Due to the fact that the lot number was not provided.A review of the device history records for the complained device is not possible.An exact root cause cannot be determined, as there was a lack of information.According to the quality standard a production error and a material defect can be excluded.Furthermore according the instruction for use the following points and caution must be observed: " - prior to each use, inspect the product for loose, bent ,brocken, cracked, worn or fractured components.- do not use the product if it is damaged or defective.Set aside the product if it is damaged.- replace any damaged components immediately with original spare parts.[.] thermal injuries to patient/users due to insufficient insulation of leads in active accessories! [.] the insulation of this product has been tested and approved by the manufacturer for 20 reprocessing cycles.Its durability in clinical practice depends on specific intraoperative use and reprocessing conditions at the hospital.- prior each use, inspect the product for: damage or surface changes to the insulation.- immediately put aside damaged or inoperative products and send them to aesculap technical service, see technical service.[.] - prior to each use, visually inspect the product for surface changes to insulation.[.] risk of injury and/or malfunction! - always carry out a function check prior to using the product.[.]" (abstract of the ifu).

Manufacturer Narrative

Investigation results: visual investigation: we made a visual inspection of the product.Here we found quirks, scratches and grooves.Additionally we detected charred parts and heavily stressed working ends.Furthermore the product was send to the quality assurance of the production department for further analysis.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: furthermore we assume that the product was most likely reprocessed over 20 cycles due to the manufacturing date of 10.2013.The insulation is tested and verified to can withstand 20 reprocessing.Additionally the service life will depend on the individual intraoperative usages und the specific reprocessing conditions.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.

Manufacturer Narrative

Further analysis has shown that the tweezers are in poor condition and the insulation is damaged in several places.The tweezers have a clear puncture and the guide is braised together.No fault could be detected on the production side as the surface testings were according to the specifications.Conclusion and measures / preventive measures: furthermore we assume that the product was most likely reprocessed over 20 cycles due to the manufacturing date of 10.2013.The insulation is tested and verified to can withstand 20 reprocessing.Additionally the service life will depend on the individual intraoperative usages und the specific reprocessing conditions.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

Additional involved component: gk281 - bipol.Cable 4m fixed pin 28.6mm aag flat.

• Brand Name: CASPAR BIPOLAR FORCEPS 2.0X125/220MM
• Type of Device: BIPOLAR COAGULATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10174103
• MDR Text Key: 197107006
• Report Number: 9610612-2020-00230
• 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,Followup,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GK980R
• Device Catalogue Number: GK980R
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GK281.