MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°-30°, ESG TURIS; ELECTRODES, PROBES

Model Number WA22706S

Device Problem Explosion (4006)

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

Event Date 06/21/2023

Event Type  malfunction  

Manufacturer Narrative

Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 218619 with internal positive quality control samples and negative quality control swabs.All test results were valid and performed as expected.Additionally, the manufacturing records and quality control release testing was reviewed for test kit part number 195-160/ lot 218619, test base part number 195-430h/ lot 215895.The lot met the required release specifications (b)(4).Abbott diagnostics scarborough was unable to determine the exact root cause of the unconfirmed false negative result; however, it could possibly be related to issues including the self-test user performance, interpretation of the result, or the specific patient sample.

Event Description

The customer reported to olympus, the surgeon activated the high frequency-resection electrode "plasmaloop" near a guidewire and the loop exploded and damaged the scope lens.The surgeon stated that the loop reacting to the guidewire caused damage to the lens of the scope.The issue occurred during a therapeutic, benign prostatic hyperplasia resection procedure.The procedure was completed.The issue did not impact the outcome of the procedure.There were no reports of patient harm.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°-30°, ESG TURIS
• Type of Device: ELECTRODES, PROBES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17400430
• MDR Text Key: 319807600
• Report Number: 9610773-2023-02016
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761085356
• UDI-Public: 14042761085356
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K171965
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22706S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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