MAUDE Adverse Event Report: LEONHARD LANG GMBH MEGADYNE; ELECTROSURGICAL DISPERSIVE ELECTRODE

Model Number	RS271A30
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Retained samples of the concerned lot number were inspected visually, electrically and mechanically.All electrodes were within limits, no failure could be detected.The user stated in his report that they have been encountering similar electrode contact issues (pads not adhering) repeatedly.The distributor distributes about (b)(4) pieces of this model annually on average.There is only one other complaint for this issue for an unknown lot number at an unknown location.We are requesting further information on how the skin is prepared for dispersive electrode placement in this hospital.We will provide a follow-up report once we receive further information.
Event or Problem Description
On november 09th 2019 we have been informed about an incident involving a dispersive electrode.A cauterize vessels robotic hysterectomy surgical procedure was performed at (b)(6) hospital in (b)(6) 2019.A megadyne dispersive electrode catalog number 0855c (our model rs271a30) and an unknown generator were used.The initial report was provided with the user's med watch report number: # 3900420000-2019-8005.The user report stated: "electrosurgical unit was in use to cauterize vessels during robotic hysterectomy.Megadyne electrosurgical patient return electrode in place.When surgeon went to use the esu, it alarmed.Pad was not adhering to patient therefore the esu would not operate.The surgeon was encountering bleeding and needed esu to operate.The return electrode pads from this company have been routinely not adhering to the patient causing this issue repetitively.Pad was checked by circulator and compressed and esu would then operate and vessel was cauterized." the distributor further stated "there were no patient consequences reported.The device is not available for return." we have requested several times for additional information and have not received any.
Additional Manufacturer Narrative
Retained samples of the concerned lot number were inspected visually, electrically and mechanically.All electrodes were within limits, no failure could be detected.The user stated in his report that they have been encountering similar electrode contact issues (pads not adhering) repeatedly.The distributor distributes about (b)(4) pieces of this model annually on average.There is only one other complaint for this issue for an unknown lot number at an unknown location.After several requests for further information on how the skin is prepared for dispersive electrode placement in this hospital we have been informed that "no additional information has been received concerning this event.No photos are available.This file has been completed and is in closed status.".We therefore consider the investigation closed.
Event or Problem Description
On november 09th, 2019 we have been informed about an incident involving a dispersive electrode.A cauterize vessels robotic hysterectomy surgical procedure was performed at (b)(6) hospital in (b)(6) 2019.A megadyne dispersive electrode catalog number 0855c (our model rs271a30) and an unknown generator were used.The initial report was provided with the user's med watch report number: # (b)(4).The user report stated: "electrosurgical unit was in use to cauterize vessels during robotic hysterectomy.Megadyne electrosurgical patient return electreode in place.When surgeon went to use the esu, it alarmed.Pad was not adhering to patient therefore the esu would not operate.The surgeon was encountering bleeding and needed esu to operate.The return electrode pads from this company have been routinely not adhering to the patient causing this issue repetitively.Pad was checked by circulator and compressed and esu would then operate and vessel was cauterized.".The distributor further stated "there were no patient consequences reported.The device is not available for return.".We have requested several times for addtional information and have not received any.

• Brand Name: MEGADYNE
• Common Device Name: ELECTROSURGICAL DISPERSIVE ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• MDR Report Key: 9414968
• Report Number: 8020045-2019-00030
• Device Sequence Number: 18966231
• Product Code: GEI
• UDI-Device Identifier: 39005531507778
• UDI-Public: (01)39005531507778
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K063161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/02/2020
• Device Model Number: RS271A30
• Device Catalogue Number: 0855C
• Device Lot Number: 171102-2402
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2019
• Supplement Date Received by Manufacturer: 11/09/2019
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Weight: 130