MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH WORKING ELEMENT, ACTIVE, FOR TURIS; RIGID ENDOSCOPE WORKING GUIDE

Model Number WA22060B

Device Problem Sparking (2595)

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

Event Date 11/26/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was not confirmed.The device evaluation did not identify any malfunction of the high frequency resection electrode.A review of the device history record for the affected lot number found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a definitive root cause could not be determined because the electrode was evaluated to meet the specification.Olympus will continue to monitor the field performance of this device.

Event Description

The customer reported to olympus, the, hf-cable had an electric arc between two hf-cable attachment pins from resectoscope during a prostate operation.The doctor was not affected, and the equipment was changed.They were using turis-electrode.The patient was not harmed but it took quite long time to change all equipment.The prostate procedure was finished successfully with the new set of devices.The procedure was extended for 20 minutes with the patient under anesthesia.The patient did not develop a permanent disability or permanent damage that caused substantial disruption in their ability to conduct normal life functions, and no additional medical or surgical intervention was required to preclude permanent impairment of a body function or damage to a body structure that is associated with the use of the olympus device.This report is related to the following linked patient identifiers: (b)(6) and (b)(6).

• Brand Name: WORKING ELEMENT, ACTIVE, FOR TURIS
• Type of Device: RIGID ENDOSCOPE WORKING GUIDE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18354033
• MDR Text Key: 330866212
• Report Number: 9610773-2023-03683
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K030194
• 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
• Report Date: 12/19/2023

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: WA22060B
• Device Lot Number: 4YW-0030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2004
• 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
• Treatment: ESG-400; SLING; WA00014A; WA22366A