MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS; RESECTOSCOPE

Model Number A42011A

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

Patient Problems Ecchymosis (1818); Hemorrhage/Bleeding (1888); Laceration(s) (1946); Rupture (2208); Unspecified Gastrointestinal Problem (4491)

Event Date 06/15/2023

Event Type  Injury  

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.

Event 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 # 5307w140009 related patient identifier# (b)(6), outer sheath, 8.5 mm / 26 fr., 2 stopcocks, rotatable, model- wa2t430a, serial # (b)(6).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 (this report) 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).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record (dhr) was unable to be reviewed for this device since the lot 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 cause for the reported issue is likely a complication during the procedure.During resection, cutting and coagulation, thermal decomposition of the rinsing fluid creates a detonable mixture of gaseous hydrogen (h2) and oxygen (o2), also known as oxyhydrogen or oxyhydrogen.Activation of the rf current in the presence of flammable gases may cause the gases to ignite or explode.This can result in bladder perforation or puncture, exogenous burns, or other injuries.Since the device was not returned for inspection, and the dhr was unable to be reviewed, a definitive root cause cannot be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS
• Type of Device: RESECTOSCOPE
• 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: 17316039
• MDR Text Key: 319094229
• Report Number: 9610773-2023-01870
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761023658
• UDI-Public: 04042761023658
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K931994
• 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,Followup
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A42011A
• Device Catalogue Number: A42011A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: HF UNIT "ESG-400" WB91051W, SN (B)(6); HF-RESECTIONELECTRODE MODEL WA22306D, SN (B)(6); OUTER SHEATH, MODEL WA42021A, SN (B)(6); TELESCOPE "OES ELITE¿, MODEL WA42021A, SN (B)(6); WORKING ELEMENT, MODEL WA22367A SN UNK
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 74 YR
• Patient Sex: Male