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

Model Number OTV-S7H-1D

Device Problem Poor Quality Image (1408)

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

Event Date 03/26/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that the camera head image had interference due to defective cable.The issue was observed during reprocessing.The field service engineer was onsite and confirmed there were horizontal stripes in the image, but the object is visible.No delays or patient harm was associated with this event.

Manufacturer Narrative

The device was returned to olympus for a device evaluation, and the customer¿s allegation was confirmed.The image was noisy occasionally due to damaged cable, and the coupler was rusty and could not be removed.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if additional information becomes available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, poor communication occurred due to damaged cable and noise on the image occurred.The cause of the defective cable could not be identified.Damage to the camera cable can be prevented by following the instructions for use which states: ¿do not coil the camera cable with a diameter of less than 20 cm.¿ ¿never excessively pull the camera cable but straighten it gradually when it is coiled.¿ ¿never excessively bend, pull, twist, coil, squeeze, or crush the camera cable.¿ ¿do not use excessive force when wiping the external surfaces of the camera cable.¿ ¿never attempt to lift the entire assembly by the camera cable while the camera head is attached to the endoscope.¿ ¿never use a clamp or forceps to attach the camera cable to another object.¿ olympus will continue to monitor field performance for 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16792866
• MDR Text Key: 313808480
• Report Number: 3002808148-2023-04088
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170141645
• UDI-Public: 04953170141645
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OTV-S7H-1D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2016
• 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