MAUDE Adverse Event Report: GYRUS ACMI, INC. FOOT SWITCH, DOUBLE, FOR, ESG-400

Model Number	WB50402W
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The foot switch was not sent to olympus for investigation.And therefore, no technical report is available.A review of the device history record could not be performed since the manufacturing date could not be determined.Due to the fact, that all olympus generators are subjected to an extensive final test before delivery.It can be assumed with a high degree of probability, that this device was also manufactured according to valid instructions and met all of its specifications.Based on the results of the investigation, the causes for e433 errors are as follows: 1.Interference of the esg-400 generator; due to scattered electromagnetic interfering fields (temporary fault).2.The operator activates the footswitch during generator booting (temporary fault caused by user action).3.A defective footswitch (temporary fault, short circuit in the plug).4.A defective footswitch (temporary fault, defective reed contact).5.A faulty cable connection between hvps board and generator board (temporary or permanent fault).6.A faulty cable connection for the output signal between generator board and relay board (temporary or permanent fault).7.A defective transformer tr1 at the generator board (permanent fault).8.A defective current transformer at the generator board (permanent fault).9.A defective impedance converter at the generator board (permanent fault).10.A defective peak value rectifier at the generator board (permanent fault).11.A defective activation for the output stage of the generator board (permanent fault).12.No or a too low supply voltage of the hvps board (permanent fault).13.Too low output voltage due to a poorly switching high-frequency power amplifier at the generator board (permanent fault).14.A defective hvps board (short circuit at the mos transistors, permanent fault).15.A defective motherboard (short circuit at the ntc1, permanent fault).16.A defective motherboard (defective adc, permanent fault).17.Defective tsv diodes at the relay board (permanent fault).It is likely the malfunction was, due to component failure.However, user fault cannot be completely ruled out.This issue is addressed in the instructions for use (ifu): a suitable replacement device must be provided during an application.Any error messages that may appear during operation are triggered by the safety system of the esg-400 and communicated visually and acoustically to the user.They are part of the device's own security concept.In particularly critical cases, further use of the device is prevented by the security system until the error has been corrected.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
Olympus was informed after an upgrade during an annual maintenance, the customer high frequency electro-surgical generator was having problems with several errors.During the device investigation olympus, found it cannot be ruled out that error message e433 was caused by a defective double foot switch.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction of the foot switch found during evaluation.This mdr is related to patient identifier: (b)(6) (generator).

• Brand Name: FOOT SWITCH, DOUBLE, FOR, ESG-400
• Common Device Name: FOOT SWITCH, DOUBLE, FOR, ESG-400
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17046651
• Report Number: 3003790304-2023-00215
• Device Sequence Number: 17404409
• Product Code: GEI
• UDI-Device Identifier: 04042761076807
• UDI-Public: 04042761076807
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K203682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/01/2023

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 Model Number: WB50402W
• Device Catalogue Number: WB50402W
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: WB91051W HF UNIT "ESG-400"
• Patient Sex: Unknown