MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 12°

Model Number	WA22503D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.This report is related to the following patient identifier: (b)(4).
Event or Problem Description
It was reported during a therapeutic transurethral resection of the prostate (turp) procedure, while using the high-frequency resection electrode an intravesical oxyhydrogen explosion occurred in which the patient's bladder was perforated several times.The patient had to undergo emergency surgery, the bladder was reconstructed, and the bladder function was restored.The operating time was extended by approximately 3 hours while the patient was under general anesthesia.No further patient impact was reported.
Event or Problem Description
It was reported that there was no defect with the olympus devices, and the devices were functioning properly.Additionally, in a discussion with the operation manager (who was present during the operation), it is not believed that an olympus device could have caused the oxyhydrogen explosion.All the devices were inspected prior to use and the maintenance intervals had been adhered to in accordance with the law.Furthermore, the hoses used were also not leaking.The customer noted, "the explosion of oxyhydrogen gas is a very rare risk in this operation, which has nothing to do with the devices used.".
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide additional information received through follow up (b5).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, it is likely that the reported event occurred due to procedural complication during the operation.During resection, cutting and coagulating, thermal decomposition of the purge fluid produces a detonation-capable mixture of gaseous hydrogen (h2) and oxygen (o2), also known as oxyhydrogen or oxyhydrogen.Activating the radio frequency (rf) current in the presence of flammable gases can cause the gases to ignite or explode.This can result in bladder perforation or puncture, exogenous burns or other injuries.However, the subject device was not returned, and the root cause of the reported event could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 12°
• Common Device Name: HF-RESECTION ELECTRODE
• 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: 20339193
• Report Number: 9610773-2024-02388
• Device Sequence Number: 8054930
• Product Code: FAS
• UDI-Device Identifier: 14042761068205
• UDI-Public: 14042761068205
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: WA22503D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CLV-180 EVIS EXERA II XENON LIGHT SOURCE; CV-180 EVIS EXERA II VIDEO SYSTEM CENTER (7643854); WA22366A RIGID ENDOSCOPE WORKING GUIDE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male