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

Model Number OTV-S7H-1D-F08E

Device Problem Connection Problem (2900)

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

Event Date 02/19/2024

Event Type  malfunction  

Event Description

It was reported that the subject device had a poor connection before procedure.There were no reports of patient harm.

Manufacturer Narrative

There is no udi because it is not sold in the us.The device was returned to olympus for evaluation and the customer's allegation was confirmed.The poor connection is due to a malfunction of the camera cable.The device evaluation also found the following functional abnormalities: 1- no image output.2- camera cable is broken.3- there is a white flaw in the image.Based on the results of the investigation, no nonconformities were found related to this complaint.A device history review was completed and revealed that the storage period of the dhr is 15 years according to ombs s_4.2.5_01_001.Since the equipment in question was manufactured more than 15 years ago, the dhr could not be verified.This issue is addressed in the instructions for use (ifu): the following statement is found in the "warning" section of the "storage" section of the instruction manual: "when wiping the outer surface of the camera cable, do not wipe the camera cable.When wiping the outer surface of the camera cable, do not rub the camera cable strongly.There is a possibility that the camera cable may break." olympus will continue to monitor the field performance of this device.

• Brand Name: 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: 18947127
• MDR Text Key: 338554119
• Report Number: 3002808148-2024-31584
• Device Sequence Number: 1
• Product Code: FET
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K955404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OTV-S7H-1D-F08E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2024
• 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