MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-Q260J

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

Patient Problems Air Embolism (1697); Fistula (1862); Hemorrhage/Bleeding (1888); Perforation (2001); Obstruction/Occlusion (2422); Ascites (2596); Unspecified Hepatic or Biliary Problem (4493)

Event Type  Injury  

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.

Event Description

Olympus reviewed the following literature titled "long-term outcomes of direct endoscopic necrosectomy for complicated or symptomatic walled-off necrosis: a korean multicenter study".This multicenter retrospective study was aimed to assess the long-term outcomes of direct endoscopic necrosectomy (den) following complicated or symptomatic walled-off necrosis (won) and severe necrotizing pancreatitis.The study included 60 patients, who underwent endoscopic transmural drainage (etd) as the first procedure, followed up by direct endoscopic necrosec¬tomy (den), if required.Assessments were done for the primary long-term clinical outcomes, such as recurrence of the symptomatic/ complicated won and late complications following den.And, among the secondary outcomes, it was to evaluate the initial treatment success and den-related early complication rates.Initial etd was performed after a median duration of 34 days from the onset of pancreatitis.If the patient¿s condition did not improve even during etd, they had undergone den to improve clinical outcomes.The study reported a clinical success rate of 85%, with a 35% complication rate and a 5% mortality rate.The multivariate analysis suspected bacterial/fungal won infection as the risk factor for den failure or major den complications requiring intervention or surgery.The study concluded that den should be performed meticulously while minimizing damage to the viable pan¬creatic parenchyma with adequate antibiotic escalation.Adverse events (number of patients), [procedure related complications with den]: den failure (need rescue surgery) - (6); massive bleeding requiring radiologic intervention - (9); visceral perforation - (3); duodenal or colonic fistula - (5); others(included air embolism, and cutaneous fistula) - (2).[long-term follow-up after den]: pancreatic exocrine insufficiency - (4); newly developed diabetes mellitus (dm) - (9); chylous ascites - (1); recurrent small bowel obstruction - (1).

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: EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL 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: 13759755
• MDR Text Key: 292203834
• Report Number: 8010047-2022-04381
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K954451
• 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: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-Q260J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2022
• 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