MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. HD AUTOCLAVABLE CAMERA HEAD

Model Number OTV-S7PROH-HD-12E

Device Problem Erratic or Intermittent Display (1182)

Patient Problem Insufficient Information (4580)

Event Date 02/27/2024

Event Type  malfunction  

Event Description

It was reported that during preparation for a therapeutic procedure, the device presented a flash screen.No additional information was provided.

Manufacturer Narrative

The device was not returned to olympus for evaluation.The information obtained from this complaint and the investigation results did not lead to the identification of the cause of the occurrence.A definitive root cause was unable to be determined.A device history review of the current product was conducted, and no problems were found.The instructions for use (ifu) indicate: ¦chapter 4 operation (warning) ¿ if an abnormal endoscopic image/function occurs and returns to its normal condition by itself, the equipment has malfunctioned.In this case, immediately stop the use and slowly withdraw the endoscope from the patient.Continued use of such equipment may cause more severe damage to the equipment and/or patient injury, such as bleeding and/or perforation.·if the endoscopic image on the monitor should unexpectedly disappear or freeze during a procedure and cannot be restored, turn the video system center off and then on again.If the image still does not appear, immediately turn the video system center off.Disconnect the camera head from the endoscope and carefully withdraw the endoscope from the patient, while viewing the endoscopic image through the endoscope¿s eyepiece.In addition, be sure to prepare another camera head to avoid interruption of the procedure ·intense endoscopic illumination may cause mucosal burns.When endoscopes are used with high intensity (e.G.Xenon) light sources, they can concentrate intense light on a relatively small area of the mucosal surface.Always use the minimum level of illumination necessary for adequate viewing.Whenever possible, avoid close, stationary viewing and do not leave the distal end of the endoscope close to mucous membranes for a long time.Olympus will continue to monitor the field performance of this device.

• Brand Name: HD AUTOCLAVABLE CAMERA HEAD
• Type of Device: CAMERA HEAD
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18996836
• MDR Text Key: 339149790
• Report Number: 3002808148-2024-31745
• Device Sequence Number: 1
• Product Code: FET
• UDI-Device Identifier: 04953170228834
• UDI-Public: 04953170228834
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K955404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OTV-S7PROH-HD-12E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: OTV-S7PRO