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

Catalog Number 01942

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent an unknown surgery in 2019 and the electrosurgical device was used.During surgery, the electrode broke off and was removed from the patient.

Manufacturer Narrative

Date sent to the fda: 01/10/2020.Additional h-3 summary: it determined the brittle fracture of the active tip can be attributed to activation of the electrode tip inside the beak of the resectoscope.Product ifu advising the user not to operate the electrodes in the beak of the sheath.

• Brand Name: 4M.M. ELECTRODE FOR BIPOLAR RE
• Type of Device: COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9365188
• MDR Text Key: 175034129
• Report Number: 2210968-2019-90230
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• PMA/PMN Number: K111751
• 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: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2024
• Device Catalogue Number: 01942
• Device Lot Number: UGY1904170
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2019
• Patient Sequence Number: 1