MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH WORKING INSERT, ALBARRAN, ONE WAY; WORKING INSERTS WITH ALBARAN LEVER

Model Number	A20971A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2019
Type of Reportable Event	Malfunction
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 an unspecified therapeutic cystoscopy procedure, the surgeon noticed foreign particles in the patient¿s bladder, which had come off the cystoscope during the procedure.However, no fragment remained inside the patient since the particles were reportedly retrieved.No further information was provided but there was no report about an adverse event or patient injury.
Additional Manufacturer Narrative
The suspect medical device was returned to the manufacturer for evaluation/investigation.The evaluation/investigation confirmed that the working insert shows distinct signs of wear and tear on the whole of the instrument.There are sharp edges at the distal end of the instrument, the albarran pull rods are slightly deformed, and there are several dents on the optical tube.The adhesive in the gap between tube and main body has been worn out by frequent reprocessing and fragments of it are missing.The article was last repaired in july 2013 and has been in use since then.Therefore, in view of the long period of use of the subject device, the root cause of the reported phenomenon can most likely be attributed to use-related wear and tear.Since it is clearly stated in the instructions for use, the product has to be visually inspected and tested before use, this event/incident was attributed to use error.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 on olympus side with no further actions.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 INSERT, ALBARRAN, ONE WAY
• Common Device Name: WORKING INSERTS WITH ALBARAN LEVER
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 9178634
• Report Number: 9610773-2019-00140
• Device Sequence Number: 2762529
• Product Code: GCP
• UDI-Device Identifier: 04042761020367
• UDI-Public: 04042761020367
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2019

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: A20971A
• Device Catalogue Number: A20971A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 11/08/2019
• 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 CYSTOSCOPE SHEATH, 25FR. (A20915A)