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

Model Number	A20972A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/03/2021
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 ureteral stent placement procedure, the raising wire at the distal end of the device got bent and could no longer be returned to 0 degrees.When removing the device for replacement, the patient¿s ureter was injured and bleeding occurred.However, the intended procedure was completed using a similar device but the patient¿s hospitalization was prolonged due to the injury.
Additional Manufacturer Narrative
The suspect medical device was returned to the manufacturer for evaluation/investigation.The investigation confirmed that the pull wires of the albarran lever are severely bent.Consequently, the function of the albarran is no longer provided.This damage was most likely caused by external force or improper handling during preparation for use or reprocessing.Thus, this event/incident was attributed to use 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 working insert without showing any abnormalities.The case will be closed on olympus side with no further actions.However, the reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• Brand Name: WORKING INSERT, ALBARRAN, TWO 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: 11965268
• Report Number: 9610773-2021-00160
• Device Sequence Number: 14588590
• Product Code: GCP
• UDI-Device Identifier: 04042761020374
• UDI-Public: 04042761020374
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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: A20972A
• Device Catalogue Number: A20972A
• Device Lot Number: 21102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 08/09/2021
• 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: UNSPECIFIED RIGID MIRROR; UNSPECIFIED SHEATH; UNSPECIFIED RIGID MIRROR; UNSPECIFIED SHEATH
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention