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

Model Number WA50012A

Device Problem Break (1069)

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

Event Date 01/08/2023

Event Type  malfunction  

Event Description

Olympus (oekg) was informed, during preparation for use, the customer discovered that the cover glass of distal tip (endoeye, autoclavable video telescope) is defective.The customer reported event was found at an unspecified event.No death or injury and no impact to patient or other has been reported to olympus.

Manufacturer Narrative

The device was returned to the olympus repair center but the investigation is still in progress.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

Olympus was informed, during preparation for use, the customer endoeye, high definition autoclavable video telescope's cover glass at the distal end is defective.No death or injury and no impact to patient or other has been reported to olympus.

Manufacturer Narrative

The device evaluation confirmed the customer¿s reported problem.The coverglass at the distal end of the insertion tube is cracked.Other observations noted during the inspection is, the charged coupled device is defective as the scope is producing white pixels (dots) on the image and the gray protective video cable has a cut.A review of the device history records (dhr) showed there is no non-conformity associated with this device with respect to the described issue and the device was manufactured according to valid instructions and met all specifications.The investigation by the legal manufacturer determined that there is no manufacturing, material or processing related cause for this failure mode.The exact cause of the customer¿s reported cracked coverglass cannot be conclusively be determined, however, based on the information provided the cause is potentially due to improper handling (impact, drop, fall).In general, the end-user is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.Olympus will continue to monitor complaints for this device.

• Brand Name: VIDEO TELESCOPE "ENDOEYE", 10 MM, 30°, PAL, HD COMPATIBLE, AUTOCLAVABLE
• Type of Device: AUTOCLAVABLE VIDEO TELESCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16301403
• MDR Text Key: 309499132
• Report Number: 9610773-2023-00420
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 03/07/2023

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: WA50012A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/09/2023
• Initial Date FDA Received: 02/04/2023
• Supplement Dates Manufacturer Received: 02/07/2023
• Supplement Dates FDA Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2009
• 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