MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE; RIGID VIDEO LAPAROSCOPE

Model Number WA50042A

Device Problems Electrical /Electronic Property Problem (1198); Poor Quality Image (1408)

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

Event Date 02/06/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, the endoeye hd ii video telescope was displaying stripes in the image.There were no reports of patient or user harm associated with this event.The subject device was subsequently evaluated by olympus.The evaluation uncovered a green image that was displayed because the charged couple device (ccd) was defective.This medical device report (mdr) is being submitted to capture the reportable malfunction found during the evaluation.

Manufacturer Narrative

The subject device has been returned to olympus for evaluation, and the evaluation found the following issues: the fiber bonding in the outer tube area (distal end) was damaged, the charged coupled device unit was broken, and the protector of the video cable section was overstressed.The investigation is ongoing at this time.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This medwatch is being supplemented with additional information obtained and the manufacturer's final investigation results.During the inspection, the reported event was confirmed.Varying colored images were detected.The device was disassembled and the components were tested individually.The image error was traced back to the r-unit.Furthermore, oste identified the following: the light-guide fiber composite at the distal end was damaged by external force (impact, shock, accidental dropping).The grey protective hose under the strain relief sleeve was overstressed.A manufacturing and quality control review was performed for the affected serial number without showing any non-conformities or deviations regarding the described issues.Olympus will continue to monitor the field performance of this device.

• Brand Name: VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE
• Type of Device: RIGID VIDEO LAPAROSCOPE
• 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: 16544889
• MDR Text Key: 311307237
• Report Number: 9610773-2023-00690
• Device Sequence Number: 1
• Product Code: HET
• UDI-Device Identifier: 04042761074971
• UDI-Public: 04042761074971
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K111788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA50042A
• Device Catalogue Number: WA50042A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2019
• 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