MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH FOOTSWITCH ESG; HF-GENERATORS

Model Number	WB950243
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect medical device was not returned to the manufacturer for investigation/evaluation but to olympus medical systems corporation (omsc), japan (received at omsc on 2022-02-02).The physical device inspection performed by omsc confirmed that the functionality of the footswitch was disturbed due to a defective reed contact.Thus, the incident can be attributed to component failure.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the footswitch without showing any abnormalities.The case will be closed from olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.
Event or Problem Description
Olympus was informed that during an unspecified therapeutic procedure the surgeon first used the hot biopsy forceps with the esg-100 electrosurgical generator and then replaced the treatment instrument with a snare, but the esg-100 then could no longer be activated with the footswitch.The intended procedure was cancelled and had to be performed at a different hospital.No further information was provided.

• Brand Name: FOOTSWITCH ESG
• Common Device Name: HF-GENERATORS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): STEUTE TECHNOLOGIES GMBH & CO KG; brückenstr. 91; löhne 32584 ; GM 32584
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 16371339
• Report Number: 9610773-2023-00498
• Device Sequence Number: 20675158
• Product Code: GEI
• UDI-Device Identifier: 04042768502439
• UDI-Public: 04042768502439
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K073207
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: WB950243
• Device Catalogue Number: WB950243
• 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: 01/18/2023
• Initial Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2010
• 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 ESG-100 ELECTROSURGICAL GENERATOR; UNSPECIFIED ELECTROSURGICAL SNARE; UNSPECIFIED HOT BIOPSY FORCEPS
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown