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 Abdominal Pain (1685); Fever (1858); Fistula (1862)

Event Date 07/27/2019

Event Type  Injury  

Event Description

Olympus reviewed the following literature: "the superior approach with the stomach roll-up technique improves intraoperative outcomes and facilitates learning laparoscopic distal pancreatectomy: a comparative study between the superior and inferior approach" by takanori morikawa, et al.This retrospective study was aimed to investigate the following to describe these novel techniques for laparoscopic distal pancreatectomy (ldp) to assess the perioperative outcomes of ldp using the superior approach (sa), in which the upper border of the pancreas is dissected first to identify the root of the splenic artery compared to those of the inferior approach (ia), in ia dissection of the distal pancreas starts along the inferior margin of the pancreas after approaching the lesser sac, and to investigate the effect of the protocol on the learning curve among surgeons-in-training.A total of 45 patients underwent laparoscopic distal pancreatectomy, in which the inferior approach was used to perform distal pancreatectomies (n=20), and 25 procedures were performed using the superior approach (n=25).The stomach roll-up technique was used in all cases and the perioperative outcomes were analyzed retrospectively.The study reported a significantly shorter operation time (p < 0.001) and lower estimated blood loss (p = 0.011), with the ia than the sa.The study concluded superior approach with the stomach roll-up as a simple technique and would aid in educating surgeons on performing laparoscopic distal pancreatectomy.The authors reported the procedures were performed with one olympus device, ltf-s190-10, and other non-olympus devices and reported the following adverse events and number of patients: total morbidity - (23); major complications/ morbidity (= cd grade iiia) - (10).Pancreatic fistula grade b/c - (17), grade b pancreatic fistula.However, no cases required reoperation, and there were no deaths.Readmissions after discharge - (3): three patients were readmitted due to pyrexia (n=2) and abdominal pain (n=1).The same tendency was observed in the cohort in which patients with conversion or concomitant procedures were excluded.

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 supplemental report is being submitted to provide additional information from the author.New information added to event.

Event Description

Additional information received from the author: the patients with grade b pancreatic fistulas needed drainage treatment.There were no patients with grade c.Also, the patients re-admitted performed conservative treatments, due to delayed pancreatic fistulas.The author could not provide additional details regarding the cases of morbidity.The author provided the following details regarding the adverse events grade clavien dindo class iiia all were with grade b pancreatic fistulas.In the opinion of the author, there was no relationship between the olympus devices and adverse events reported in the study.

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: 13811414
• MDR Text Key: 292985114
• Report Number: 8010047-2022-04646
• 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: 06/07/2022

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: 02/20/2022
• Initial Date FDA Received: 03/18/2022
• Supplement Dates Manufacturer Received: 03/23/2022; 05/19/2022
• Supplement Dates FDA Received: 04/20/2022; 06/07/2022
• 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