MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC GASTROVIDEOSCOPE

Model Number GF-UE260-AL5

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

Patient Problems Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)

Event Type  Injury  

Event Description

Olympus reviewed the following literature article: "role of eus at high risk for choledocholithiasis without severe cholangitis and visible stone on cross-sectional imaging: a multicenter randomized clinical trial" by young hoon choi, et al.    this multicenter, prospective, randomized study was designed to compare the benefits and efficacy of endoscopic retrograde cholangiography (erc) with a eus-first approach in patients at high risk for choledocholithiasis.The 90 enrolled patients, were randomly assigned in a 1:1 ratio to undergo bile duct evaluation with either eus followed by erc if necessary (eus group, n = 45) or erc only (erc group, n = 45).All the patients were followed up for 6 months at 3-month intervals in the outpatient department.The primary and secondary outcomes were, any negative outcomes related to either a false-negative and the rate of diagnostic erc and hospital stay length related to endoscopy, respectively.Hospitalization possibly related to choledocholithiasis such as that for biliary pancreatitis, cholangitis, or obstructive jaundice was also recorded.The reported rate of diagnostic erc was significantly lower in the eus group (2.4% vs.47.7%; p < 0.001).Patients allocated into the eus group underwent eus first to evaluate the cbd and if cbd stone or sludge was confirmed by the eus, then subsequent therapeutic erc was performed by the same operator during the same session.On the other hand, if eus imaging did not reveal cbd stone or sludge, no additional procedure was performed.Patients allocated into the erc group underwent erc directly for confirming and clearing the cbd simultaneously.Eus examinations were performed using a radial array echoendoscope (gf-ue260; olympus optical co., (tokyo, japan) by one of three expert endoscopists with experience performing more than 1000 eus examinations for pancreatobiliary diseases.Erc procedures including sphincterotomy and stone extraction were performed in a standard manner using a video duodenoscope (tjf-260v, jf-260v, tjf-240, or jf-240; olympus, tokyo, japan).Cbd clearance was attempted using a basket or retrieval balloon or both, depending on the endoscopist¿s discretion.Endoscopic adverse events were reported to occur in one patient in the eus group and three patients in the erc group.The study concluded that, patients who were at high risk for choledocholithiasis, a eus-first strategy lessened the rate of diagnostic erc and hospitalization stay length but did not reduce the occurrence of negative outcomes related to the endoscopic procedure or the false-negative diagnosis of choledocholithiasis.Hence, the downward revision of the high-risk group to the intermediate-risk group for choledocholithiasis defined in the study need be considered.[eus group, n=42]: mild post-erc pancreatitis - (1).[erc group, n=44]: mild post-erc pancreatitis - (3); moderate cholangitis (accompanied by complicated liver cyst)- (1).  the authors reported using multiple olympus devices: gf-ue260 radial array echoendoscope, and a video duodenoscope (tjf-260v, jf-260v, tjf-240, or jf-240).The authors did not specify which video duodenoscope was used for the patients with adverse events and therefore all will be reported.The basket or balloon retrieval for cbd clearance were not identified as olympus devices.This article includes 3 reports: patient identifier (b)(6) is for the tjf-260v or jf-260v evis lucera duodenovideoscope.Tjf-260v was selected as a representative device.Patient identifier (b)(6) is for the tjf-240 or jf-240 evis duodenovideoscope.Tjf-240 was selected as a representative device.Patient identifier (b)(6) is for gf-ue260.This report is 3 of 3 for patient identifier (b)(6) is for gf-ue260.

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Concomitant medical products: if erc procedure needed, then one of the following may have been used: tjf-260v, jf-260v, tjf-240, or jf-240.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 the results of the legal manufacturer¿s investigation and additional information from the authors.New information added to event and mfr narrative.Device history records review was not performed since the serial number was not provided.Olympus ships product manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.

Event Description

The author provided additional information: the adverse events did not require any medical or surgical intervention.The physician provided his medical opinion there was no relationship between the olympus devices and adverse events.

• Brand Name: ULTRASONIC GASTROVIDEOSCOPE
• Type of Device: ULTRASONIC GASTROVIDEOSCOPE
• 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: 13733962
• MDR Text Key: 291963801
• Report Number: 8010047-2022-04288
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 04/20/2022

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: GF-UE260-AL5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2022
• Initial Date FDA Received: 03/11/2022
• Supplement Dates Manufacturer Received: 03/23/2022
• Supplement Dates FDA 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