MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 1.9 MM, 0°,210MM, AUTOCLAVABLE; AUTOCLAVABLE TELESCOPE

Model Number	A3764A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to olympus for evaluation and the customer¿s reported problem was confirmed, the objective coverglass lens at the distal end of the device is damaged.The inspection also noted the rigid outer tube is bent, and image failure due to objective coverglass lens damage.Device history records: the manufacturing and quality control review was performed for the affected lot or serial number without showing any non-conformities or deviations regarding the described issue.The cause of the reported event cannot be determined at this time as the investigation is still in progress; however, if additional information becomes available, this report will be supplemented accordingly.In general, the end-user is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.
Event or Problem Description
The customer reported the autoclavable telescope was found to have a ¿lens crack¿ during inspection before use.The scope was replaced, and the intended stent removal procedure was completed.A five-minute delay was reported with no death or injury and no impact to patient or other.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, the reported issue was likely caused by user error, improper handling, and excessive force.This supplemental report includes a correction to g2 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 1.9 MM, 0°,210MM, AUTOCLAVABLE
• Common Device Name: AUTOCLAVABLE TELESCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16651270
• Report Number: 9610773-2023-00920
• Device Sequence Number: 5367592
• Product Code: FJL
• UDI-Device Identifier: 04042761005722
• UDI-Public: 04042761005722
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K904940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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: A3764A
• Device Catalogue Number: A3764A
• Device Lot Number: 544498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2007
• 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
• Patient Sex: Unknown