MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 12°, 4 MM; HYSTEROSCOPE, GYNECOLOGY

Model Number A22001A

Device Problems Loose or Intermittent Connection (1371); Naturally Worn (2988)

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

Event Date 01/08/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.In addition to the reportable findings documented in b5, non-reportable findings are as follows; the label of the eyepiece was worn, the outer tube was from 3rd party repair, and there was no image.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.E1/establishment name: hulunbeier people's hospital (hulunbeier league people's hospital (added due to character limitation in respective field.).

Event Description

The customer reported to olympus, the telescope's image was blurry.The issue was found during preparation for use of a therapeutic urological surgery.The device was returned for evaluation.During the device evaluation, the following reportable malfunctions were found: the distal end was burnt and worn, and the blue ring of the eyepiece was loose.There was no delay or patient harm, nor was the patient under anesthesia.The procedure was able to be successfully completed using the same device.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

• Brand Name: TELESCOPE, 12°, 4 MM
• Type of Device: HYSTEROSCOPE, GYNECOLOGY
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18572245
• MDR Text Key: 333615658
• Report Number: 9610773-2024-00237
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020848
• UDI-Public: 04042761020848
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22001A
• Device Lot Number: 659468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2013
• 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: VISERA PRO VIDEO SYSTEM CENTER.