MAUDE Adverse Event Report: ETHICON INC. 4M.M. ELECTRODE FOR BIPOLAR RE; COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR

Catalog Number 1942

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).  a manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.  evaluation: visual inspection: the device was not returned in its original packaging.The active ring of the device was confirmed to be missing from the distal end of the electrode.The missing section of the active ring was not returned with the electrode.The remainder of the electrode showed no signs of damage.No connector cable was returned with the electrode.No electrical or functional testing was conducted due to the condition of the device.Closer visual examination was only conducted.Electrical test: no electrical testing conducted due to the condition of the returned device.Functional test: no functional testing conducted; due to the condition of the device.Further investigation: all fracture faces showed evidence of a brittle failure, also there were no signs of an obvious reduction on cross sectional area, indicating a non-mechanical failure mode.It was also worth noting that the fracture surfaces may have been compromised somewhat as activation may have occurred after the actual failure causing the fracture surface to be altered somewhat.No electrical or functional testing was conducted.The condition of the fracture face of the device suggests a brittle failure with no obvious signs of mechanical damage.Instances of similar failures have been seen historically, with the failure location, mode and method indicating failure due to surface (hydrogen) embrittlement.Results of the batch record review: ugy2004012 the device history record for batch referenced above was reviewed for non-conformance's related to the nature of the complaint during the manufacturing process.The results of this review indicate there were zero non-conformance regarding the nature of the complaint associated with this lot.Product release date: april 2020.Product expiry date: april 2025.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2021 and the electrode was used.It was reported that the device handle broke during the procedure and the surgery was delayed as a result.Upon evaluation of the returned sample the electrode distal end was found broken and active ring missing.No fragments were generated and the procedure was successfully completed.There were no adverse patient consequences reported.

• Brand Name: 4M.M. ELECTRODE FOR BIPOLAR RE
• Type of Device: COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GYRUS MEDICAL LTD; fortran road; cardiff CF30L T; UK CF30LT
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12072291
• MDR Text Key: 268299094
• Report Number: 2210968-2021-05841
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K111751
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1942
• Device Lot Number: UGY2004012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Date Manufacturer Received: 05/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1