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 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The results of this batch review indicate there were zero non-conformances regarding the nature of the complaint associated with the lot.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.It was reported the tip of electrode broke, provide the following: confirm that the tip broke off from the electrode? did the tip break off while the electrode was inserted in the patients cavity? if yes, was the piece of the tip that broke retrieved and removed from the patients cavity? was normal saline used as the irrigant solution used 0.9% normal saline? was the electrode only activated when the tip of the electrode was completely immersed in 0.9% sodium chloride solution? confirm procedure completed with second electrode w/no consequence to the patient? will the electrode be returned in its entirety including the piece of the electrode loop that broke?: do you have any picture of the electrode with the piece that broke off? what is the status of the device return?: if the device was shipped provide the tracking number?.

Event Description

It was reported that the patient underwent a myomectomy on (b)(6) 2019 and the electrosurgical device was used.During the procedure, in an attempt to remove the fibroid, the loop tip broke and another like loop was used.There were no patient consequences reported.Additional information has been requested.

• 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
• Manufacturer (Section G): GYRUS MEDICAL LTD; fortran road; cardiff
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9211651
• MDR Text Key: 168793206
• Report Number: 2210968-2019-88844
• 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: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2024
• Device Catalogue Number: 01942
• Device Lot Number: UGY1902014
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2019
• Initial Date FDA Received: 10/18/2019
• 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