MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number WA22306D

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

A review of the device history record and quality control review was performed for the affected lot or serial number and showed no non-conformities or deviations regarding the described issue.It has been over a year since the subject device was manufactured.The device referenced in this report was not returned to olympus for evaluation.A definitive the root cause cannot be determined at this time.Based on the results of the investigation, it is likely that the following led to the malfunction: the reported explosion is caused when the activated hf-resection electrode is in contact with oxyhydrogen.Activating hf current near flammable gas may cause the gases to ignite or explode.This can result in bladder perforation or puncture, exogenous burns, or other injury.The cause for the reported incident is very likely a procedural complication.Olympus will continue to monitor the field performance of this device.

Manufacturer Narrative

A review of the device history record and quality control review was performed for the affected lot or serial number and showed no non-conformities or deviations regarding the described issue.It has been over a year since the subject device was manufactured.The device referenced in this report was not returned to olympus for evaluation.A definitive the root cause cannot be determined at this time.Based on the results of the investigation, it is likely that the following led to the malfunction: the reported explosion is caused when the activated hf-resection electrode is in contact with oxyhydrogen.Activating hf current near flammable gas may cause the gases to ignite or explode.This can result in bladder perforation or puncture, exogenous burns, or other injury.The cause for the reported incident is very likely a procedural complication.Olympus will continue to monitor the field performance of this device.

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 # (b)(6).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.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)(this report).

• Brand Name: HF-RESECTION ELECTRODE, LOOP
• 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 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17325444
• MDR Text Key: 319234394
• Report Number: 9610773-2023-01881
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761051689
• UDI-Public: 14042761051689
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K100275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WA22306D
• Device Catalogue Number: WA22306D
• Device Lot Number: 1000114114
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: FY24-EMEA-01
• Patient Sequence Number: 1
• Treatment: HF UNIT "ESG-400" WB91051W, SN (B)(6); OUTER SHEATH, MODEL WA42021A, SN (B)(6); RESECTION SHEATH, MODEL A42011A SN UNK; TELESCOPE "OES ELITE¿, MODEL WA42021A, SN (B)(6); WORKING ELEMENT, MODEL WA22367A SN UNK
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male