MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE; TELESCOPES, AUTOCLAVABLE (WITHOUT CHANNEL)

Model Number A70941A

Device Problems Melted (1385); Scratched Material (3020)

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

Event Date 11/27/2022

Event Type  malfunction  

Event Description

An olympus representative requested a repair of a loaner unit.During preliminary evaluation and inspection, a scratched and melted cover glass was found.This mdr is being submitted due to the scratched and melted cover glass found during evaluation and inspection.No patient or user harm has been reported.

Manufacturer Narrative

The subject device has been returned to an olympus repair center and is pending evaluation and inspection.This investigation is ongoing and additional information has requested regarding the reported event.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This medwatch is being supplemented with additional information obtained and the manufacturer's final investigation results.An estimation performed by the repair center identified the following defects with the scope: scratches on the cover glass and distal end melted.Shadow visible in the image/ foreign substance in the optical system.Cause scratches on the cover glass: this failure mode is most likely caused by improper handling during use or reprocessing.Burnt residue on the distal end: the cause of this failure mode is most likely wear in combination with improper reprocessing.The residues left on the optical fibers became scorched during use as a result of the light energy.Shadow visible in image/ foreign body in the optical system: probably a scratch on the cover glass is the cause of the shadow visible in the image.Manufacturing and quality control review was performed for the affected serial number without showing any non-conformities or deviations regarding the described issues.

• Brand Name: TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE
• Type of Device: TELESCOPES, AUTOCLAVABLE (WITHOUT CHANNEL)
• 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: 16051949
• MDR Text Key: 308113197
• Report Number: 9610773-2022-00742
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K951354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: A70941A
• Device Catalogue Number: A70941A
• Device Lot Number: 506425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2005
• 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