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

Model Number A22001A

Device Problem Break (1069)

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

Event Date 11/24/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The third-party repair and evaluation found a blurred internal water vapor image due to the lens being damaged and the device's serial number was unrecognizable due to wear and tear.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 hysteroresectoscope experienced a defective light source connection.The issue was found during preparation for a therapeutic transurethral resection of the prostate procedure.The procedure was completed with a similar device (wa2t412a, lot# 807402) with no reported patient harm or procedural delay.The device was repaired by a third party.During the third-party device evaluation, damage around the tip of the lens was found.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: HYSTERORESECTOSCOPE
• 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: 18301058
• MDR Text Key: 330830376
• Report Number: 9610773-2023-03584
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020848
• UDI-Public: 04042761020848
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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,Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/11/2023

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
• Device Operator: Health Professional
• Device Model Number: A22001A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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