MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE; HF-CABLES

Model Number	WA00013A
Medical Device Problem Codes	Output Problem (3005); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
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 a therapeutic transurethral resection in saline (turis) procedure, error message e02 occurred frequently and the procedure could not be completed but had to be postponed.The intended procedure was then completed on another day with a different hf cable.No further information was provided.
Additional Manufacturer Narrative
The suspect medical device was not returned to the manufacturer for evaluation/investigation, since it was reportedly discarded by the user facility.Therefore, the evaluation/investigation was performed exclusively on the basis of the information provided by the customer.Therefore, the exact cause of the patient's outcome and the reported phenomenon could not be determined and is being judged as unknown.Furthermore, a manufacturing and quality control review could not be performed since basic data of article identification (lot number) are missing.Instead a manufacturing and quality control review was performed for the last 24 months of production 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.

• Brand Name: HF-CABLE
• Common Device Name: HF-CABLES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 11929036
• Report Number: 9610773-2021-00152
• Device Sequence Number: 19630832
• Product Code: FAS
• UDI-Device Identifier: 04042761030489
• UDI-Public: 04042761030489
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA00013A
• Device Catalogue Number: WA00013A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 06/11/2021
• 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: OLYMPUS ELECTROSURGICAL UNIT UES-40S
• Outcome Attributed to Adverse Event: Required Intervention