MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH FOOT SWITCH, DOUBLE, FOR, ESG-400; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	WB50402W
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to olympus that an electrical failure occurred and no image during the hysteroscopic myomectomy and the same problem occurred after replacing all the combined devices causing a 30-minute delay in surgery and 30 minutes extended anesthesia time.There were no error messages.The procedure was completed using other urological products.The event did not affect the diagnostic or treatment outcome.There were no reports of patient harm.This event requires 12 reports.Related patient identifiers for the first combination of devices used are as follows: (b)(6) (wa00014a / hf-cable, bipolar), (b)(6) (wa00014a / hf-cable, bipolar), (b)(6) (a42011a / resection sheath, 8 mm, for 8.5 mm/26 fr.Outer sheath, abs), (b)(6) (a42021a / outer sheath, 8.5 mm / 26 fr., 2 stopcocks, rotatable), (b)(6) (wa22366a /working element, active, for resection in saline), (b)(6) (wb50402w / foot switch, double, for, esg-400).Related patient identifiers for the second combination of devices used: (b)(6) (wb50402w / foot switch, double, for, esg-400), (b)(6) (wa22366a / working element, active, for resection in saline), (b)(6) (a42011a / resection sheath, 8 mm, for 8.5 mm/26 fr.Outer sheath, abs), (b)(6) (a42021a /outer sheath, 8.5 mm / 26 fr., 2 stopcocks, rotatable), (b)(6) (wa00014a / hf-cable, bipolar), (b)(6) (wa00014a /hf-cable, bipolar).This medwatch report is for patient identifier: (b)(6).
Additional Manufacturer Narrative
The device was not returned for analysis.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation with correction to the initial with information inadvertently left out.Additionally, to provide updates to fields (d4, d9, h3, and h4).The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was not confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the reported issue could not be determined as no fault or malfunction has been identified with the affected devices.Users occasionally report that the power output is too low or that the surgical result is insufficient.There are a number of possibilities that can result in an inadequate surgical performance.All of them can basically be traced back to insufficient power output into the tissue.Possible causes are: 1.Defective cable connection to the connected instrument.No or only intermittent power output.2.Defective hand instrument.No or only intermittent power output.3.Contamination of the hand instrument due to adhering tissue deposits.Reduced power output.4.Contact resistances at the contact points of the hand instrument reduced power output, possibly burns to the patient.5.In case of a monopolar application an incorrectly attached neutral electrode and/or a defective supply line to the neutral electrode.Reduced or only intermittent power output with the risk of burns below the applied neutral electrode.6.Incorrect setting of the power on the generator by the user.7.An insufficient adjustment of the generator reduced power output 8.A defect in the generator.Reduced or no power output in addition, the electrical conditions in the tissue of the surgical area may also cause the problem.In most cases, it is helpful to gradually increase the power level until the desired result is achieved.If it is suspected that the high-frequency generator in question is causing insufficient power output from a technical point of view, the device in question should be made available to an authorized service center for inspection.The first step to be taken here is to carry out and document a complete psc (periodical safety check) in accordance with the current service manual.If the psc was successful, the device in question must be assessed as being within the standard.If any faults are detected, these must be rectified in accordance with the service manual.In the past, however, it has been shown that there are rarely errors of this type that can actually be traced back to a device defect.In this respect, a user error can be assumed as the cause in most cases.However, a specific root cause of the phenomenon could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: FOOT SWITCH, DOUBLE, FOR, ESG-400
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17374619
• Report Number: 9610773-2023-01955
• Device Sequence Number: 11708314
• Product Code: GEI
• UDI-Device Identifier: 04042761076807
• UDI-Public: 04042761076807
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: WB50402W
• Device Catalogue Number: WB50402W
• Device Lot Number: 1307-3686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2013
• 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: HF-CABLE, BIPOLAR X2.; OUTER SHEATH, 8.5 MM / 26 FR.; RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR.; WORKING ELEMENT, ACTIVE, FOR RESECTION IN SALINE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian