MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "ULTRA", 10 MM, 0°; LAPAROSCOPE

Model Number WA4KL100

Device Problem Component Missing (2306)

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

Event Type  malfunction  

Event Description

It was reported to olympus that the telescope had a missing light source adapter lens during inspection.There was no injury or health damage due to the reported event.

Manufacturer Narrative

The device was returned to olympus.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.

Manufacturer Narrative

This supplemental report was submitted to provide the results of the evaluation and investigation.The physical evaluation confirmed the customer¿s reported problem, the light guide lens coverglass is broken.The inspection also noted the following (non-reportable defects): the serial number is faded and scratches on the eyepiece.The review of the device history records for the affected lot or serial number without showing any non-conformities or deviations regarding the described issue.The device was manufactured according to valid instructions and met all specifications.The cause of the reported event cannot conclusively be determined; however, the cause is potentially due to excessive stress/force applied to the device.Olympus will continue to monitor complaints for this device.

• Brand Name: TELESCOPE "ULTRA", 10 MM, 0°
• Type of Device: LAPAROSCOPE
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16354580
• MDR Text Key: 309304447
• Report Number: 9610773-2023-00469
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04042761082846
• UDI-Public: 04042761082846
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K150633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

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: WA4KL100
• Device Catalogue Number: WA4KL100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/12/2023
• Initial Date FDA Received: 02/10/2023
• Supplement Dates Manufacturer Received: 03/30/2023
• Supplement Dates FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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