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

Model Number	WA22066A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Date of Event	04/16/2018
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 user's experience 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 a therapeutic transurethral resection of the prostate (turp) procedure, the patient's bladder was perforated.The physician assumed that this perforation was caused by the working element.No further information was provided.However, there was no report of malfunction for any of the medical devices.
Additional Manufacturer Narrative
Additional information: device manufacture date.Device evaluation: the suspect medical device was returned to the manufacturer for evaluation/investigation.The working element was thoroughly tested.The electrical function of the ptfe body can be confirmed without any restrictions.However, the following significant signs of wear and tear were observed: the telescope seal is damaged, the guide tube for the optical system is deformed and the distal end of the guide tube is burred.The cause of this damage is most likely improper maintenance.Therefore, this damage was attributed to use error.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.The case will be closed from olympus side with no further actions but the reported event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results and retrained to correctly use the olympus medical devices.

• Brand Name: WORKING ELEMENT, ACTIVE
• Common Device Name: WORKING ELEMENTS (MONOPOLAR, BIPOLAR, FOR KNIVES, FOR PROBES)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• MDR Report Key: 7486042
• Report Number: 9610773-2018-00041
• Device Sequence Number: 16498142
• Product Code: GCP
• UDI-Device Identifier: 04042761051613
• UDI-Public: 04042761051613
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 05/28/2018

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: WA22066A
• Device Catalogue Number: WA22066A
• Device Lot Number: 106W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/16/2018
• Supplement Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 05/04/2018
• Supplement Report FDA Received Date: 05/28/2018
• 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 RESECTION ELECTRODE (LOOP); UNSPECIFIED HF RESECTION ELECTRODE (LOOP)
• Outcome Attributed to Adverse Event: Required Intervention