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

Model Number LTF-190-10-3D

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Obstruction/Occlusion (2422); Post Operative Wound Infection (2446); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp(omsc).Omsc could not review the service and manufacturing record because the serial number was not provided from the facility.There was no malfunction report of the subject device concerning the events.The exact cause could not be determined.

Event Description

On (b)(6) 2017, olympus medical systems corp(omsc) received a literature titled ¿study in treatment results after laparoscopic rectal resection using 3d endoscope system¿ that was made in public in (b)(6) digestive disease week in (b)(6)2017.The literature reported the study result of 24 cases between (b)(6) 2014 and (b)(6) 2016 compared with the result before introducing the olympus 3d endoscope system to the facility.The literature reported that complications after the surgery using the 3d endoscope were wound infection (one case), anastomotic leakage (one case) and paralytic ileus (two cases).Complications of surgery using normal endoscope were wound infection (two cases) and anastomotic leakage (six cases).In conclusion, the literature stated that the rectal resection using the 3d endocope system possibly bring improvements in accuracy in the procedure less invasive results to the operator and the system is very useful device especially for young surgeons.Omsc review the sales history record for the facility and confirmed olympus ltf-s190-10 possibly used in the procedures.This is three of four reports.

• 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: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 7016777
• MDR Text Key: 91893876
• Report Number: 8010047-2017-01730
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK123365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: LTF-190-10-3D
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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