MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BERLIN FACILITY TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE; RIGID OPTICAL LAPAROSCOPE

Model Number WA53005A

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was able to be confirmed.During the device evaluation it was observed that the light guide connector dislodged and was stuck inside of the light guide cable.It was also observed that there was light guide breakage.Lastly, it was observed that there were dents on the outer tube.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.Additional pma/510(k) numbers: k923982/ k950076.

Event Description

The customer reported to olympus the telescope, 10 mm, 30°, hd, quick lock, autoclavable had an adaptor dislodged and got stuck in the light cable.The reported issue was discovered at the user facility during maintenance of the scope.There was no patient/user harm or injury reported due to the event.

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, the root cause of the event was unable to be identified.The event likely occurred due to user error, improper handling as well as application of excessive force.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE
• Type of Device: RIGID OPTICAL LAPAROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH BERLIN FACILITY; rheinstrasse 8; teltow, brandenburg 14513 ; GM 14513
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH BERLIN FACILITY; rheinstrasse 8; teltow, brandenburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17775380
• MDR Text Key: 323759793
• Report Number: 3003724334-2023-00038
• Device Sequence Number: 1
• Product Code: EWY
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K912362
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA53005A
• Device Lot Number: 617246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2012
• 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