MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 12°, STERILE, SINGLE USE; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number WA22503D

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Internal Organ Perforation (1987)

Event Date 05/25/2022

Event Type  Injury  

Manufacturer Narrative

B3 - approximate date of (b)(6) 2022 was used as the event reportedly occurred about a year prior to notification.G4 - additional fda premarket submission number: k100275.The suspect device has not been returned to olympus.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 a patient experienced "bladder explosion" during a transuretheral resection of the prostate while using a hf-resection electrode, loop, 24 fr., 0.2 wire, large, 12°, sterile, single use, 12 pcs., for turis.The event reportedly occurred about a year prior to notification.Additional information is currently being requested for this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Attempts were performed to obtain additional information, but the customer confirm no other event details can be provided.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the reported event may be attributed to procedural complication during operation.During resection, cutting and coagulation an explosive compound of hydrogen (h2) and oxygen (o2), also known as oxyhydrogen, is generated by thermal reaction of the rinsing liquid.Activation of the hf current in the presence of inflammable gases may cause the gases to ignite or explode.This may result in bladder perforation or puncture, exogenous burns or other injuries.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 12°, STERILE, SINGLE USE
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16997205
• MDR Text Key: 315909848
• Report Number: 9610773-2023-01421
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761068205
• UDI-Public: 14042761068205
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WA22503D
• Device Catalogue Number: WA22503D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2023
• 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
• Treatment: TURIS SET; VIO (MODEL UNKNOWN)
• Patient Outcome(s): Other