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

Model Number LTF-S190-10

Device Problem Poor Quality Image (1408)

Patient Problem No Code Available (3191)

Event Date 11/18/2019

Event Type  Injury  

Manufacturer Narrative

The subject device has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that during an unspecified procedure, the abnormal endoscopic image of the subject device occurred.The user facility had no spare scope and moved to open surgery.The intended procedure was completed.There was no report of further patient injury with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device in this report was returned to olympus medical systems corp.(omsc) for evaluation.Omsc evaluated the subject device and confirmed that the abnormal endoscopic image of the subject device was duplicated.In addition, the evaluation confirmed following.The coating of the electric cable connected to the ccd (image) unit was partially missing.There were multiple scratches on the bending section rubber and the adhesive of bending section rubber.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Considering the evaluation result, it was surmised that the reported event occurred because the electric cable was short-circuited or disconnected at the part where the coating of the electric cable was missing.The missing of the coating was possibly caused that the subject device was contacted with an instrument such as a trocar during procedure and excessive force was applied.

• Brand Name: ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE
• Type of Device: FLEX DEFLECTABLE VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9471205
• MDR Text Key: 187514692
• Report Number: 8010047-2019-04329
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K111425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: LTF-S190-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other