MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12°; HF-RESECTION ELECTRODES

Model Number	A22201A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	10/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect medical device was not returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient's outcome and the reported phenomenon could not be determined and is being judged as unknown.However, since there was no report of a malfunction of an olympus medical device, it is assumed that the device met its specification and was in standard.Furthermore, a manufacturing and quality control review could not be performed since basic data of article identification (lot number) are missing.The case will be closed from olympus side with no further actions.However, the reported phenomenon will be recorded for trending and surveillance purposes.
Event or Problem Description
Olympus was informed about a literature study called "intravesical explosion during transurethral resection of bladder tumor: a case report".The case at hand investigated on intravesical explosion during transurethral resection of bladder tumor (tur-bt).After surgery, no obvious damage was found to the intestines or other abdominal structures, but a large number of blood clots were found in the bladder.Following careful exploration of the bleeding sites and complete hemostasis, the residual tumor tissue was completely resected, after which the bladder was checked carefully.A test of bladder infusion showed no suture leakage.The pelvic and abdominal drainage tubes were placed, and the incision closed.This study concludes that although rare, intravesical explosions can cause serious consequences, and the loud explosion can also lead to a profound psychological shadow on the patient.Careful operative techniques and special precautions can reduce the risk of this complication.There was in total one adverse event (bladder rupture) on one patient.However, there was no malfunction of an olympus medical device reported.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12°
• Common Device Name: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O.; telickova 457/29; prerov 75124 ; EZ 75124
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 16085820
• Report Number: 9610773-2023-00053
• Device Sequence Number: 2147480
• Product Code: GCP
• UDI-Device Identifier: 04042761021302
• UDI-Public: 04042761021302
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/03/2023

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: A22201A
• Device Catalogue Number: A22201A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown