MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. MEGADYNE; ELECTROSURGICAL DISPERSIVE ELECTRODE

Model Number	RS271A30
Medical Device Problem Codes	Energy Output Problem (1431); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Retained samples of the same lot have been inspected visually and tested electrically.Mechanical tests were performed on 3 retained samples.All tested samples were found to perform within limits.No faults were detected.The involved devices have not been made available to us.After several requests for further information none has been made available to us.No conclusion can be drawn what might have caused the malfunction.We will provide a follow-up report once we receive further information.
Event or Problem Description
On may 23th, 2022 we have been informed about a malfunction involving a dispersive electrode.A hot snare polypectomy procedure was performed at baptist health hospital in the us.A megadyne dispersive electrode catalog number 0855c (our model rs271a30) and an unknown generator were used.The initial report mdr report #: mw5109443 was forwarded by fda to our representative in the us mrs.(b)(6).The mdr report #: mw5109443 stated: "padded pt with cautery ground on rt flank for hot snare polypectomy.Upon use of snare, it didn't cauterized the polyp and ended up doing cold snare on pt.Checked all connections and pressed the ground pad firmly on pt's back but still unable to do cauterization as intended to do.Right flank is dry and no hair present upon applying the pad.Once the pad is removed, site is clear, dry and intact and the pad is noted not to be as sticky as had been in the past even if you fold it to stick both sticky sides together, it does not stick on each other and easily snap off.Fda safety report id # (b)(4)." no further information was provided despite repeated requests.
Additional Manufacturer Narrative
The affected 38600 robi metal outer sheath was returned to the manufacturer on 2022-08-25 and the investigation was finished on (b)(6) 2022.Upon inspection of the sheath, it could be confirmed that a small piece has broken off from the sheath surface at the distal end.There is also another crack visible on the surface, but no piece has broken off here.Based on the damages found on the sheath, it is concluded that the most probable root cause was an overload during use or reprocessing.The following safety-relevant information is stated in the corresponding ifu of the product: "3.3 correct handling > check the product for the following points before and after every use: - completeness - good working order - rough surfaces left inadvertently - sharp corners - burred edges - correct assembly of the components - functionality > do not leave broken-off components inside the patient.> do not overload the product with mechanical stress.3.4 damaged products damaged products can result in injury to patients, users or third parties.> before each use, check all components of the product for damage.> do not use damaged products.".
Event or Problem Description
On may 23th, 2022 we have been informed about a malfunction involving a dispersive electrode.A hot snare polypectomy procedure was performed at baptist health hospital in the us.A megadyne dispersive electrode catalog number 0855c (our model rs271a30) and an unknown generator were used.The initial report mdr report #: mw5109443 was forwarded by fda to our representative in the us mrs.Elaine duncain.The mdr report #: mw5109443 stated: "padded pt with cautery ground on rt flank for hot snare polypectomy.Upon use of snare, it didn't cauterized the polyp and ended up doing cold snare on pt.Checked all connections and pressed the ground pad firmly on pt's back but still unable to do cauterization as intended to do.Right flank is dry and no hair present upon applying the pad.Once the pad is removed, site is clear, dry and intact and the pad is noted not to be as sticky as had been in the past even if you fold it to stick both sticky sides together, it does not stick on each other and easily snap off.Fda safety report id # (b)(4)." no further information was provided despite repeated requests.

• Brand Name: MEGADYNE
• Common Device Name: ELECTROSURGICAL DISPERSIVE ELECTRODE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; 4545 creek road; cincinnati OH 45242
• Manufacturer (Section G): LEONHARD LANG GMBH; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• Manufacturer Contact: bernhard ladner ; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 14751964
• Report Number: 8020045-2022-00015
• Device Sequence Number: 19386518
• Product Code: GEI
• UDI-Device Identifier: 39005531507778
• UDI-Public: (01)39005531507778
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/13/2025
• Device Model Number: RS271A30
• Device Catalogue Number: 0855C
• Device Lot Number: 220113-2401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown