MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE

Model Number LTF-190-10-3D

Device Problem Component Missing (2306)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/16/2022

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

The customer reported to olympus the reprocessing staff identified the screw that secures the angle release lever was missing.It is unknown when the screw was lost and there is a possibility the screw fell into a patient.The customer stated the device is also used as a light when performing a laparotomy.A request for additional information is in progress.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the customer.

Event Description

Additional information received from the customer: this device used on a patient last at (b)(6) 2022.The procedure at that time is completed without any problems.It seems that the inspection before use was done, but the relevant part pointed out this time has not been carried out.During cleaning, the middle material staff (outsourced contractor) happens to find it.The endoscopist who was using it did not touch (operate) the angle lock lever in the first place, so he did not feel that there was something wrong.There were no malfunctions during the prior procedure either and no issues reported by the patient.No diagnostic testing was performed on the patient to locate the missing screw.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation and the results of the device history records (dhr) review.The dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The olympus service center evaluated the device and identified the following: the screw of the angulation lock lever was detached and the glue for fixing the screw of the angulation lock lever was peeled off.Judging from the fact that the angulation lock lever was not repaired after delivery of the device in 2014, there was a scratch in the angulation lock lever, and the glue for fixing the screw of the angulation lock lever was peeled off, the screw might have been gradually loosened and dropped because accumulation of stress from the outside.Peeling off of the glue for fixing the screw of the angulation lock lever was presumed to be caused by aged deterioration of the glue resulted from accumulation of chemical stress due to reprocessing during long term usage.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is likely due to usage.Olympus will continue to monitor field performance for this device.

• Brand Name: ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE
• Type of Device: FLEX 3D DEFLECTABLE VIDEOSCOPE
• 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: 14704101
• MDR Text Key: 294844996
• Report Number: 8010047-2022-10107
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170340710
• UDI-Public: 04953170340710
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LTF-190-10-3D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 06/15/2022
• Supplement Dates Manufacturer Received: 06/22/2022; 08/23/2022
• Supplement Dates FDA Received: 07/18/2022; 09/12/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/03/2014
• 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
• Patient Outcome(s): Other