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 Problem Seroma (2069)

Event Date 06/11/2021

Event Type  Injury  

Event Description

Olympus reviewed a literature titled "long-term outcomes of single-incision versus multiport laparoscopic totally extra-peritoneal inguinal hernia repair: a single institution experience of 186 consecutive cases" by yozo suzuki et al.This retrospective study was conducted to compare the long-term outcomes of single-incision totally extraperitoneal (s-tep) inguinal hernia repair and conventional multiport totally extraperitoneal (m-tep) inguinal hernia repair.This article includes 2 complaints for the 2 different olympus devices used by the authors and reported adverse events: (b)(6) - ltf-s190-5; (b)(6) - ltf-s190-10.Complications that occurred within 30 days of surgery: seroma (n=15).This report is 2 of 2 for (b)(6) - ltf-s190-10.

Manufacturer Narrative

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

Event Description

The author provided additional information: the author stated most of the patients with adverse events healed spontaneously but it is possible puncture drainage was performed on symptomatic individuals.In the author's medical opinion, there was no relationship between olympus device and the events.The serial numbers for the olympus devices are unknown.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the author.B5 updated.

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: 13862431
• MDR Text Key: 287697812
• Report Number: 8010047-2022-04834
• 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,Followup
• Report Date: 07/05/2022

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?: 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
• Initial Date Manufacturer Received: 02/23/2022
• Initial Date FDA Received: 03/23/2022
• Supplement Dates Manufacturer Received: 03/23/2022; 06/06/2022
• Supplement Dates FDA Received: 04/20/2022; 07/05/2022
• 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