MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, BUTTON; ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES

Model Number WA22557C

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

Patient Problem Internal Organ Perforation (1987)

Event Date 12/08/2023

Event Type  Injury  

Event Description

A user facility reported that after twenty minutes into a transurethral resection of bladder (turb) while using hf-resection electrode, button, 24-28 fr., 12° and 30°, sterile, single use, 12 pcs., along with the working element, there was no resection.The doctor instructed the nurses to check the saline solution and it was ok so they attempted again with success.There was a unexpected loud sound followed by smoke.It was stated that the physician was scared and swiftly pulled the instrument from the patient resulting in a bladder perforation.The procedure was transitioned to an open procedure to close the perforation.The patient was stated to be stable after the open surgery.This mdr requires 2 reports.The related patient identifiers are as follows: (b)(6): hf-resection electrode, button, 24-28 fr., 12° and 30°, sterile, single use, 12 pcs., for turis, model wa22557c.(b)(6) : working element, passive, for resection in saline, model wa22367a.This medwatch report is for patient identifier (b)(6), model wa22557c.

Manufacturer Narrative

The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

• Brand Name: HF-RESECTION ELECTRODE, BUTTON
• Type of Device: ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES
• 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: 18452268
• MDR Text Key: 332257238
• Report Number: 9610773-2024-00089
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: SI
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WA22557C
• Device Lot Number: 1000067064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2020
• 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: CONNECTION CABLE - BOWA; ELECTROSURGICAL UNIT - STORZ; WORKING ELEMENT, MODEL WA22367A
• Patient Outcome(s): Required Intervention