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

Model Number LTF-190-10-3D

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

Patient Problem Pain (1994)

Event Date 07/21/2021

Event Type  Injury  

Event Description

Olympus reviewed the following literature: "three-dimensional versus two-dimensional laparoscopic myomectomy: a randomized controlled trial." objective: this study aimed to compare the surgical outcomes of three-dimensional (3d) and two-dimensional (2d) laparoscopic myomectomy.Study design.A total of 64 patients with symptomatic uterine fibroids were randomly assigned to either the 3d (n = 32) group or the 2d group (n = 32).The primary outcomes were the operative blood loss and change in hemoglobin levels.The secondary outcome was operative time.Results: there were no differences in the baseline demographics between the two groups.The 3d and 2d groups were not significantly different in terms of operative blood loss (129.5 ± 86.5 ml vs.140.9 ± 89.8 ml, p = 0.412), change in serum hemoglobin levels (1.4 ± 1.6 g/dl vs.1.6 ± 1.6 g/dl, p = 0.553), and operative time (77.4 ± 37.8 min vs.82.4 ± 35.4 min, p = 0.344).Furthermore, no differences were observed between the groups with regard to other surgical outcomes.Conclusion: the 3d imaging system had no additional surgical benefit in laparoscopic myomectomy compared with to the conventional 2d imaging system.One patient in the 3d group experienced severe postoperative pain that required a visit to the emergency room on postoperative day 10, but it was managed conservatively without readmission.

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.Please see the updates in b3, b5, h6, and h10.The device history record was unable to be reviewed for this device since the serial 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.

Event Description

The customer provided additional information on 14apr2022: serial numbers are unknown, there was no relationship between the olympus devices and the adverse events, there was no malfunction during the study, and according to the information, there is no need for a device return.

• 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: 14056082
• MDR Text Key: 294153898
• Report Number: 8010047-2022-05981
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170340710
• UDI-Public: 04953170340710
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K123365
• 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: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LTF-190-10-3D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2022
• 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