MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HD AUTOCLAVABLE CAMERA HEAD

Model Number OTV-S7PROH-HD-10E

Device Problems No Display/Image (1183); Moisture Damage (1405)

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

Event Type  malfunction  

Manufacturer Narrative

The device evaluation revealed: wire pull or torn, a leak in probe unit, foreign materials in distal end of light guide cover, a dent in the plug unit, dents in the probe unit, bumps on distal end of forceps port, angulation of the wire stopper, a broken angulation wire in bending tube, scratches on up down knob, damaged universal cord, and serial number plate was unreadable.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

The customer reported to olympus the device cable was disconnected.Upon inspection and testing of the customer returned device, it was observed that no image is displayed due to flooding of the head.There was no harm or user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the approved final investigation.Correction to g3 of the initial medwatch.The aware date should be 30-jan-2022.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, the definitive root cause of the flooding could not be determined.Olympus will continue to monitor field performance for this device.

Event Description

The customer provided additional information on 10may2022: the defect was found in repair quote inspection.The customer report is disconnection.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 8 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, the root cause of the faulty ap and dr patient boards (printed circuit boards) and looseness of the scope socket could not be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: HD AUTOCLAVABLE CAMERA HEAD
• Type of Device: CAMERA HEAD
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13594477
• MDR Text Key: 296462628
• Report Number: 8010047-2022-03528
• Device Sequence Number: 1
• Product Code: FET
• UDI-Device Identifier: 04953170252914
• UDI-Public: 04953170252914
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OTV-S7PROH-HD-10E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2014
• 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