MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH FOOT SWITCH, DOUBLE, FOR, ESG-400; HF-GENERATORS

Model Number	WB50402W
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Olympus was informed that after the inspection of the electrosurgical generator ¿esg-400¿ which was found to meet its specification, the affected foot switch was connected to the generator resulting in displaying error message e433.No further information was provided.
Additional Manufacturer Narrative
The suspect medical device was not returned to the manufacturer for evaluation/investigation but to an olympus regional repair center (rrc) in india (returned to rrc on 2022-06-22).The evaluation confirmed the occurrence of error message e433 which is triggered by the generator¿s safety system.In case of critical errors, the safety system will not permit any further use of the generator until the error is rectified.In the case at hand, this was triggered by a defective footswitch caused by the operator activating the footswitch during generator booting and/or a defective footswitch.In addition, the cable sheath was torn open which was most likely caused by a mechanical impact on the outer sheath of the cable.The cable may have been pulled over a sharp edge or it may have been subjected to excessive pressure.However, the exact cause cannot be determined retrospectively.Based on the age of the reported footswitch, we can rule out aging effects.It must therefore be assumed that the reported issue is attributable to improper handling by the user.Since the insulation of the cable is damaged, the footswitch must no longer be used.A manufacturing and quality control review was performed for the affected serial number of the hf generator without showing any abnormalities.The case will be closed on olympus side with no further actions, but the reported event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results.

• Brand Name: FOOT SWITCH, DOUBLE, FOR, ESG-400
• Common Device Name: HF-GENERATORS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; rheinstrasse 8; teltow 14513 ; GM 14513
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 15040576
• Report Number: 9610773-2022-00280
• Device Sequence Number: 12494985
• Product Code: GEI
• UDI-Device Identifier: 04042761076807
• UDI-Public: 04042761076807
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/18/2022

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 Model Number: WB50402W
• Device Catalogue Number: WB50402W
• Device Lot Number: 1807-0830
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2018
• 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: OLYMPUS ELECTROSURGICAL GENERATOR 'ESG-400'
• Patient Sex: Unknown