MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH WORKING ELEMENT, PASSIVE; WORKING ELEMENTS (MONOPOLAR, BIPOLAR, FOR KNIVES, FOR PROBES)

Model Number	WA22067A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	09/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect medical device has not yet been 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, if the suspect medical device is returned for evaluation / investigation or additional significant information becomes available, this report will be updated.
Event or Problem Description
Olympus was informed that during an unspecified therapeutic prostate resection procedure an explosion occurred inside the patient¿s bladder causing a rupture of the internal muscularis of the patient¿s bladder.The intended procedure was canceled and open surgery was started.The patient was subsequently hospitalized.
Additional Manufacturer Narrative
Device manufacturer date the suspect medical device was not returned to the manufacturer for evaluation/investigation but to olympus china.The investigation/evaluation did not reveal any malfunctions or abnormalities of the working element.Furthermore, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the working element without showing any abnormalities.Based on the information available, the exact cause of the reported phenomenon and the patient¿s outcome could not be determined and is being judged as unknown.However, based on the customer's description and our experience, the reported incident can most likely be attributed to use error.As clearly stated as a warning note in the instructions for use, if the hf current is activated while the distal end of the resectoscope is located in the accumulated gases or in their direct vicinity, this may cause the gases to ignite or explode.The case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes.

• Brand Name: WORKING ELEMENT, PASSIVE
• Common Device Name: WORKING ELEMENTS (MONOPOLAR, BIPOLAR, FOR KNIVES, FOR PROBES)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 9104087
• Report Number: 9610773-2019-00126
• Device Sequence Number: 2383871
• Product Code: GCP
• UDI-Device Identifier: 04042761051620
• UDI-Public: 04042761051620
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

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: WA22067A
• Device Catalogue Number: WA22067A
• Device Lot Number: 195W
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 04/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED HF GENERATOR
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention