MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "OES ELITE", 4 MM, 12°, HD, AUTOCLAVABLE; TELESCOPE, RIGID, ENDOSCOPIC

Model Number WA2T412A

Device Problem Crack (1135)

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

Event Date 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the evaluation found the internal lens was damaged, and the outer tube was bent.The damaged eyepiece could not be confirmed.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, the telescope "oes elite", 4 mm, 12°, high definition had a cracked eyepiece cup and displayed a shadowy image.The issue was found during preparation for use for a therapeutic, hysteroscopy procedure.The procedure was completed using a similar device.There were no reports of patient harm.

• Brand Name: TELESCOPE "OES ELITE", 4 MM, 12°, HD, AUTOCLAVABLE
• Type of Device: TELESCOPE, RIGID, ENDOSCOPIC
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland 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: 18390644
• MDR Text Key: 331532562
• Report Number: 9610773-2023-03760
• Device Sequence Number: 1
• Product Code: FBP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151191
• 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: Other
• Type of Report: Initial
• Report Date: 12/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA2T412A
• Device Lot Number: 816881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2023
• 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-190.