MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR.

Model Number	A22201C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The electrode was not returned for evaluation.The investigation of this event is ongoing and if additional information is received this report will be supplemented accordingly.
Event or Problem Description
Olympus received an initial report (ahs mdip # 8075) from alberta health service that states during a bladder resection procedure, approximately 3mm of loop broke off and fell into the patient¿s bladder.The surgeon was resecting a bladder tumor when the phenomenon occurred.According to the report, the surgeon irrigated the patient¿s bladder with sterile water to flush out the cautery loop piece.However, the loop piece was too small to confirm if it flushed out.There was no patient injury reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the legal manufacturer investigation and additional information from the customer.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The legal manufacturer was unable to determine the root cause.The lm reported that the most probable cause for the reported event is as follows: since the product for this info complaint was not returned to oste, our investigation is based solely on the information provided by the customer.The reported issue can most likely be attributed to wear and tear.The loop at the distal end of the electrode wears out during use and may break, burn or melt.A22201c, lot: unknown.It is impossible to perform a dhr review with a missing lot number.Instead, the manufacturing and quality control review was performed for the last 24 months of production without showing any non-conformities or deviations regarding the described issue.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR.
• Common Device Name: RESECTION ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 11306830
• Report Number: 8010047-2021-02483
• Device Sequence Number: 17078089
• Product Code: GCP
• UDI-Device Identifier: 14042761036648
• UDI-Public: 14042761036648
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: foreign,health professional,u
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A22201C
• Device Catalogue Number: A22201C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1