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

Model Number A22001A

Device Problems Break (1069); Mechanical Problem (1384); Detachment of Device or Device Component (2907)

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

Event Date 05/29/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to an olympus repair center for evaluation and the customer¿s reported issue was confirmed.Device evaluation found detachment of light guide connection part.In addition to confirming the customers reported issue the device evaluation also found that there was bad illumination due to dirt on the light guide connector.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Event Description

The customer reported to olympus, there was detachment issue with the light guide connection of the scope.The issue was found at the end of an unspecified therapeutic procedure.The procedure was completed with no reported delay there were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that the event occurred due to user error, improper handling and application of excessive force.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 12°, 4 MM
• Type of Device: RESECTOSCOPES
• 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: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17253150
• MDR Text Key: 318453636
• Report Number: 9610773-2023-01797
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020848
• UDI-Public: 04042761020848
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2023

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 Catalogue Number: A22001A
• Device Lot Number: 692318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/06/2023
• Initial Date FDA Received: 07/03/2023
• Supplement Dates Manufacturer Received: 09/26/2023
• Supplement Dates FDA Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2015
• 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: WA03300A.