MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OP-TELESCOPE, 10 MM, 6°, 5.5 MM CHANNEL, OCULAR ANGLE 45°, AUTOCLAVABLE; RIGID SCOPE

Model Number A52001A

Device Problem Break (1069)

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

Event Date 02/08/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that during reprocessing, the rotation valve was found to be broken.The intended procedure was completed with another device.No reported delay.No patient injury reported.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was not confirmed.The device evaluation found: the image was shadowy due to displacement of the lens.The rotation valve (7029275) was damaged, the investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

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.It has been over 13 years since the subject device was manufactured.Based on the results of the investigation, it is likely the damaged rotation valve occurred due to excessive force by the customer.However, a definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: OP-TELESCOPE, 10 MM, 6°, 5.5 MM CHANNEL, OCULAR ANGLE 45°, 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: 16526918
• MDR Text Key: 311570755
• Report Number: 9610773-2023-00733
• Device Sequence Number: 1
• Product Code: EWY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K912362
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A52001A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2010
• 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: OTV-SPRO