MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH VIDEO TELESCOPE "ENDOEYE 3D", 10 MM, 30°; RIGID VIDEO SCOPE

Model Number WA50082A

Device Problem Optical Discoloration (2999)

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

Event Date 12/01/2022

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device was not returned to the manufacturer for investigation/evaluation nor to any repair center.Therefore, the investigation/evaluation was performed exclusively on the basis of the information provided by the customer.Since the suspect medical device was not returned to olympus the exact cause of the reported image discoloration could not be determined and is being judged as unknown.A manufacturing and quality control review was performed for the affected serial number of the video telescope without showing any abnormalities.The case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation result.

Event Description

Olympus was informed that during preparation for use for an unspecified procedure, the video telescope displayed a yellow image.The intended procedure was completed with a similar device and there was no report about an adverse event or patient injury.

Manufacturer Narrative

Additional information: b5 - describe event or problem; h6 - type of investigation; device evaluation: contrary as initially announced the suspect medical device was returned to to olympus shanghai (osh) (returned to osh on 2023/01/10).The evaluation at osh could not confirm the reported foggy yellow image.Therefore, the cause for the reported image failure remains unknown.A manufacturing and quality control review was performed for the affected serial number of the video telescope without showing any abnormalities.The case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation result.

Event Description

Olympus was informed that during preparation for use for an unspecified procedure, the video telescope displayed a foggy yellow image.The intended procedure was completed with a similar device and there was no report about an adverse event or patient injury.

• Brand Name: VIDEO TELESCOPE "ENDOEYE 3D", 10 MM, 30°
• Type of Device: RIGID VIDEO SCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstra¿¿e 61; hamburg
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 16076672
• MDR Text Key: 308475474
• Report Number: 9610773-2022-00812
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K193026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA50082A
• Device Catalogue Number: WA50082A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/30/2022
• Supplement Dates Manufacturer Received: 01/23/2023
• Supplement Dates FDA Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2021
• 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