MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE

Model Number WA22507D

Device Problem Dull, Blunt (2407)

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

Event Date 01/27/2023

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to olympus at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.

Event Description

The customer reported to olympus that the f-resection electrode, loop, 24 fr., 0.2 wire, large, 30°, sterile, single use, 12 pcs., for turis, did not cut and showed failure with the warning to check the cables and irrigate with normal saline fluid during a transurethral resection of the prostate.The cables and connections were checked, and the device was reset; however, the failure persisted.The device was replaced, and the procedure was completed.There was a 3-hour delay due to the reported issue.There was no harm or user injury reported from the delay.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, although the exact cause could not be determined, there was likely a break in contact between the electrode and the feed dog, or there was damage in the electrode itself.In addition, other possible causes may have been activation of the electrode in an environment where air was present, and/or use of a non-conductive liquid during a bipolar cutting operation.The event can be detected/prevented by following the instructions for use (ifu) which states: ¿a suitable replacement device must be provided during an application.¿ this supplemental report includes information added to d8 and d9.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE
• 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: 16509053
• MDR Text Key: 310946619
• Report Number: 9610773-2023-00699
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761068236
• UDI-Public: 14042761068236
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K100275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2023

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
• Device Operator: Health Professional
• Device Model Number: WA22507D
• Device Catalogue Number: WA22507D
• Device Lot Number: 1000093551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2023
• Initial Date FDA Received: 03/08/2023
• Supplement Dates Manufacturer Received: 05/30/2023
• Supplement Dates FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ESG-400/B003667.
• Patient Outcome(s): Other