MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "TRUEVIEW II", 2.7 MM, 0°, AUTOCLAVABLE; RIGID SCOPE

Model Number A70960A

Device Problems Break (1069); Image Display Error/Artifact (1304)

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

Event Date 03/08/2024

Event Type  malfunction  

Event Description

It was reported that the autoclavable rigid scope had blurry images and broken lenses.The issue occurred during the receipt inspection.There were no reports of patient harm.

Manufacturer Narrative

To date, the customer have not returned the device for evaluation.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

It was reported that the autoclavable rigid scope had broken lenses.The issue occurred during the receipt inspection for a diagnostic arthroscopy procedure that was completed using a similar device.There were no reports of patient harm.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected fields: b5, d8, e1, e2, e3, g2, h6 - problem code (remove 1304 as it is representing a non-reportable event).Additional information added to field h4 and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 3 years since the subject device was manufactured.The customer's allegation of broken lenses of the telescope was confirmed.Based on the results of the investigation, it is likely that the event was caused by the excessive force by the customer.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

The device evaluation found the following: blurry image,good angle of view, crack on objective and rod lenses.Recommended replacement within the scope of repair.The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: TELESCOPE "TRUEVIEW II", 2.7 MM, 0°, AUTOCLAVABLE
• Type of Device: RIGID SCOPE
• 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: 18960738
• MDR Text Key: 339124197
• Report Number: 9610773-2024-00826
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 04042761010627
• UDI-Public: 04042761010627
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K951354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A70960A
• Device Lot Number: 800550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2021
• 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