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

Model Number LTF-S190-10

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Seroma (2069); Hernia (2240)

Event Date 05/25/2019

Event Type  Injury  

Event Description

Olympus reviewed the following literature article: "laparoscopic inguinal hernia repair with a joystick-guided robotic scope holder (soloassist ii®): retrospective comparative study with human assistant" by yasushi ohmura, et al.This retrospective non-randomized study was aimed to evaluate the clinical feasibility and usefulness of soloassist by comparing perioperative results before and after its introduction in laparoscopic inguinal hernia repair.A total of 182 inguinal hernia patients were included, 82 cases were completed with a human scope assistant (n=82), while soloassist was used in 100 cases (n=100), all of them were retrospectively evaluated the perioperative results before and after the introduction of soloassist.The study reported that 19 patients had bilateral type i inguinal hernias and in 13 patients, bilateral type ii inguinal hernias and all the operations with soloassist were carried out laparoscopically as solo surgery without any system-specific complications.However, the operation time was reported to be significantly (p = 0.01) shorter in the soloassist group than in the human assistant group.In conclusion, the study supported the application of soloassist for laparoscopic inguinal hernia repair due to its feasibility and no device-related adverse events.The authors reported performing the procedures with one of two olympus devices: endoeye flex or endoeye flex 3d and reported the following adverse events: seroma (n = 3); port site hernia (n=1) with early re-operation; intra-operative bleeding with a range of 3mls - 100mls.This article includes 2 reports: (b)(6) is for ltf-s190-10; (b)(6) is for ltf-190-10-3d.This report is 1 of 2 for (b)(6) for ltf-s190-10. .

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.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13826273
• MDR Text Key: 292984850
• Report Number: 8010047-2022-04669
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170310386
• UDI-Public: 04953170310386
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LTF-S190-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2022
• 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; Required Intervention