MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OUTER SHEATH, 8.5 MM / 26 FR., 2 STOPCOCKS, ROTATABLE; HYSTEROSCOPE (AND ACCESSORIES)

Model Number	A42021A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ecchymosis (1818); Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946); Rupture (2208); Unspecified Gastrointestinal Problem (4491)
Date of Event	06/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that at the end of endoscopic surgery for transurethral resection for prostatic adenoma (weighing around 50 gm) a violent intravesical explosion of a probable gaseous nature occurred during the use of clot current.The procedure was immediately stopped, and exploratory laparotomy was required, revealed endo peritoneal laceration of the bladder.Reportedly, the bladder was completely ruptured with bleeding and intravesical displacement of intestinal loops with some ecchymosis.As such, complex exploratory surgery was performed to repair the bladder.Post surgery, the patient was transferred to the intensive care unit for further care.Upon follow-up no additional information could be received regarding the patient's current condition.There was 6 devices involved in this event reported under the following patient identifiers: related patient identifier # (b)(6), hf unit "esg-400", model- a42021a, serial # (b)(6).Related patient identifier # (b)(6), outer sheath, 8.5 mm / 26 fr., 2 stopcocks, rotatable, model- wa2t430a, serial #(b)(6) (this report).Related patient identifier # (b)(6), telescope "oes elite", 4 mm, 30°, hd, autoclavable, model- wa2t430a serial # (b)(6).Related patient identifier # (b)(6), resection sheath, 8 mm, for 8.5 mm/26 fr.Outer sheath, abs, model- a42011a, serial # unknown.Related patient identifier # (b)(6), working element, passive, for resection in saline, model- wa22367a, serial # unknown.Related patient identifier # (b)(6), hf-resection electrode, loop, 24 fr., 0.2 wire, medium, 30°, sterile, single use, 12 pcs., for turis model- wa22306d, serial #(b)(6).
Additional Manufacturer Narrative
The device referenced in this report was not returned to olympus for evaluation.The root cause cannot be determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is possible the suggested event occurred due to a procedural complication during the surgery.During resection, cutting and coagulation, a detonable mixture of gaseous hydrogen (h2) and oxygen (o2) ¿ also called oxyhydrogen ¿ is formed by the thermal decomposition of the irrigation fluid.Activating the high frequency current while flammable gases are present may cause the gases to ignite or explode.This can result in bladder perforation or puncture, exogenous burnings, or other injury.However, the root cause of the suggested event could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: OUTER SHEATH, 8.5 MM / 26 FR., 2 STOPCOCKS, ROTATABLE
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• 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: 17313109
• Report Number: 9610773-2023-01861
• Device Sequence Number: 6187925
• Product Code: HIH
• UDI-Device Identifier: 04042761023665
• UDI-Public: 04042761023665
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K897003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: A42021A
• Device Catalogue Number: A42021A
• Device Lot Number: 21311-0005
• 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: 06/17/2023
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HF UNIT "ESG-400" WB91051W, SN (B)(6).; HF-RESECTIONELECTRODE MODEL WA22306D, SN (B)(6).; RESECTION SHEATH, MODEL A42011A SN- UNK.; TELESCOPE "OES ELITE¿, MODEL WA42021A, SN (B)(6).; WORKING ELEMENT, MODEL WA22367A SN UNK.
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male