MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 30°, 4 MM; HYSTEROSCOPE (AND ACCESSORIES)

Model Number A22002A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/05/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, the telescope, 30°, 4 mm had a metal retaining pin detached.The issue was found during reprocessing.There were no reports of patient harm.

Manufacturer Narrative

The subject device was returned to an olympus repair center for evaluation and the customer¿s reported issue was confirmed.The device evaluation found direction pin was detached, the light guide (lg) fibers were broken which caused loss of light transmission, the tube was bent due to wrong handling with too much load on outer tube and the image was blurry dur to lens/meniscus damage.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

• Brand Name: TELESCOPE, 30°, 4 MM
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18190162
• MDR Text Key: 328742509
• Report Number: 9610773-2023-03374
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020855
• UDI-Public: 04042761020855
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K897003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22002A
• Device Lot Number: 785636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CV-290.