MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 10 MM, 0°, HD, QUICK LOCK, AUTOCLAVABLE; RIGID SCOPE

Model Number WA53000A

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

It was reported to olympus that a telescope was sent in for evaluation and repair for a broken tip.During the evaluation, olympus staff discovered reportable malfunctions.There was no patient injury or adverse event reported to olympus.

Manufacturer Narrative

The device was returned to olympus for evaluation and repair.The investigation is still in progress; therefore, the root cause of the reported defect cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.In general, the customer is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.Olympus will continue to monitor the field performance of this device.Additional pma/510(k): k923982/ k950076.

Manufacturer Narrative

B5 (information was inadvertently omitted), d5, g2 (added selection), h8 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, the root cause could not be determined.It is likely the reported event occurred due to the use of excessive force from improper handling in combination with wear and tear.Olympus will continue to monitor field performance for this device.

Event Description

The customer reported that the light guide cable connector has become loose and the gold plating on the outer tube has worn off.This report is being submitted for the defective light guide connector.It was also noted that the device was inspected before use and that the intended procedure was completed without delay using a different scope.

• Brand Name: TELESCOPE, 10 MM, 0°, HD, QUICK LOCK, AUTOCLAVABLE
• Type of Device: RIGID SCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16832043
• MDR Text Key: 314179070
• Report Number: 9610773-2023-01166
• Device Sequence Number: 1
• Product Code: EWY
• UDI-Device Identifier: 04042761052757
• UDI-Public: 04042761052757
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K912362
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA53000A
• Device Catalogue Number: WA53000A
• Device Lot Number: 669060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2014
• 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