MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OP TELESCOPE, 7°, 11 FR. X 220 MM, 7.5 FR. CHANNEL, ANGLED OCULAR; RIGID SCOPE

Model Number	A37025A
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Fragmentation (1261); Image Display Error/Artifact (1304); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect medical device has already been returned to olympus.However, since the evaluation/investigation is still ongoing, the exact cause of the user's experience and the reported phenomenon has not been determined yet.This report will be updated if additional significant information becomes available or once the evaluation/investigation has been completed.
Event or Problem Description
A rigid scope was returned to olympus for repair with a reported "cloudy image".There is no indication that the reported damage occurred during a procedure and there was no report about an adverse event or patient injury.
Additional Manufacturer Narrative
Additional information: b5 - describe event or problem; h6 - medical device problem code; device evaluation: the suspect medical device was not returned to the manufacturer for investigation/evaluation but to olympus medical system corporation (omsc) in japan (returned to omsc on 2022/11/28).The evaluation at omsc confirmed the reported cloudy image and found the outer tube damaged at the distal end.Furthermore, foreign material was found on the cover glass of the eyepiece.All findings were caused by mechanical force and can thus be attributed to use error.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected serial number of the rigid scope without showing any abnormalities.The case will be closed on olympus side with no further actions and the user will be informed about the investigation results.
Event or Problem Description
A rigid scope was returned to olympus for repair with a reported "cloudy image".During the inspection at the service center the distal end of the outer tube was found to be broken.There is no indication that the reported damage occurred during a procedure and there was no report about an adverse event or patient injury.

• Brand Name: OP TELESCOPE, 7°, 11 FR. X 220 MM, 7.5 FR. CHANNEL, ANGLED OCULAR
• Common Device Name: RIGID SCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 16049981
• Report Number: 9610773-2022-00733
• Device Sequence Number: 6346873
• Product Code: FGA
• UDI-Device Identifier: 04042761023214
• UDI-Public: 04042761023214
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K853486
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2023

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: A37025A
• Device Catalogue Number: A37025A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2022
• Supplement Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 12/27/2022
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2009
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown