MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH WORKING ELEMENT, ACTIVE, FOR RESECTION IN SALINE; ENDOSCOPIC ELECTROSURGICAL UNIT

Model Number WA22366A

Device Problem Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus that the hf-cable, bipolar when used to output high frequency signals, sparks were generated, and a hole was created in the doctor¿s glove.The event occurred during a therapeutic procedure.There was no patient harm associated with the event.

Manufacturer Narrative

This supplemental report is to provide a correction to the initial medwatch report.Initially, this complaint was submitted as a reportable malfunction conservatively.However, upon further review, this is being corrected to a non-reportable event.The initial medwatch reported the subject device had a sparks generate and create a hole in the doctor's glove; however; per the legal manufacturer, this issue is not likely to cause or contribute to death or serious injury if the malfunction were to recur.

• Brand Name: WORKING ELEMENT, ACTIVE, FOR RESECTION IN SALINE
• Type of Device: ENDOSCOPIC ELECTROSURGICAL UNIT
• 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: 18229085
• MDR Text Key: 329263534
• Report Number: 9610773-2023-03417
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04042761066235
• UDI-Public: 04042761066235
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K030194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

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
• Device Operator: Health Professional
• Device Model Number: WA22366A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 11/29/2023
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1