MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH PUNCH, FOR BLADDER STONES, OPTICAL; SUCTION/IRRIGATION ACCESSORIES

Model Number	A3661
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2022
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 procedure the ceramic insulations at the distal end of two resection sheaths broke off one after the other and fragments fell into the patient's bladder.Presumably, this may have been caused by the punch for bladder stones used during the procedure, which allegedly was slightly deformed at its distal end.No fragments remained inside the patient since they were reportedly broken into smaller pieces and then flushed out using an ellik evacuator.This caused a certain delay to the procedure, which however, was not considered medically relevant for the patient.No further information was provided but there was no report about an adverse event or patient injury.This incident has already been reported with mfr report # 9610773 - 2022 - 00120 and mfr report # 9610773 - 2022 - 00121 submitted for the two olympus resection sheaths used during the procedure.
Additional Manufacturer Narrative
The suspect medical device was returned to the manufacturer for evaluation/investigation.The evaluation/investigation confirmed a deformation, more specifically a dent and several scratches, at the distal end of the bladder stone punch.Due to this damage, when combined with the a22041a resection sheaths, the bladder stone punch scraped against the inside of the sheaths causing the ceramic insulation at the distal end of the resection sheaths to break off.The dent and scratches inside the opening of the punch were most likely caused by using great force when fragmenting a bladder stone.As a consequence, this event/incident can most likely be attributed to user error.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the bladder stone punch without showing any abnormalities.The case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• Brand Name: PUNCH, FOR BLADDER STONES, OPTICAL
• Common Device Name: SUCTION/IRRIGATION ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 13994565
• Report Number: 9610773-2022-00122
• Device Sequence Number: 5089976
• Product Code: GCP
• UDI-Device Identifier: 04042761005432
• UDI-Public: 04042761005432
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2022

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: A3661
• Device Catalogue Number: A3661
• Device Lot Number: 20Y03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2 OLYMPUS RESECTION SHEATHS , 24 FR. (A22041A); UNSPECIFIED ELLIK EVACUATOR
• Patient Sex: Unknown