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

Model Number GF-UCT240-AL5

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

Patient Problem Pancreatitis (4481)

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 article, "diagnostic approach using ercp-guided transpapillary forceps biopsy or eus-guided fine-needle aspiration biopsy according to the nature of stricture segment for patients with suspected malignant biliary stricture" by yun nah lee, jong ho moon, hyun jong choi et al.This study aimed to evaluate the usefulness of a diagnostic approach using ercp-guided transpapillary forceps biopsy (tpb) or eus-fnab according to the characteristics of suspected mbs.Consecutive patients diagnosed with suspected mbs with obstructive jaundice and/or cholangitis were enrolled prospectively.Ercp with intraductal ultrasonography (idus) and tpb were performed as initial diagnostic procedures.Based on the results of imaging studies and idus, all mbs were classified as extrinsic or intrinsic type.If the malignancy was not confirmed by tpb, eus-fnab for extrinsic type or second tpb for intrinsic type was performed.Among a total of 178 patients, intrinsic and extrinsic types were detected in 88 and 90 patients, respectively.The diagnostic accuracy of first tpb was significantly higher in the intrinsic than in the extrinsic type (81.8% vs.67.8, p = 0.023).In 33 patients with extrinsic type and negative for malignancy on first tpb, the diagnostic accuracy of eus-fnab was 90.9%.In 19 patients with intrinsic type and negative for malignancy on first tpb, the diagnostic accuracy of second tpb was 84.2%.The diagnostic accuracies of the combination of initial tpb with eus-fnab and second tpb were 96.7% and 96.6%, respectively.A diagnostic approach using eus-fnab or tpb according to the origin of mbs is considered effective to improve the diagnostic accuracy of mbs with negative for malignancy on first tpb.The authors used multiple olympus devices and did not specify which olympus device may have caused or contributed to the mild pancreatitis.This article includes 5 reports: (b)(6): fb-39q; (b)(6): jf--260v; (b)(6): tjf-260v; (b)(6): gf-uct24; (b)(6): um-g20-29r.This is report 4 of 5 for (b)(6): gf-uct24.

Event Description

Additional information was provide by the author: the author provided his medical opinion regarding the relationship between the patients' with pancreatitis and the olympus devices.Dr.(b)(6) stated the pancreatitis could be caused by the procedure itself and not the olympus device.He stated treatment was not needed, the patients were monitored since the pancreatitis was mild.

Manufacturer Narrative

This supplemental report is being submitted to provide the author's response with additional information and the legal manufacturer's investigation.New information added to event.The device history records (dhr) for this device could not be reviewed since the serial number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer was unable to determine the probable cause of the adverse events, the device was not returned for evaluation.

• Brand Name: ULTRASONIC GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND 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: 13544230
• MDR Text Key: 290461525
• Report Number: 8010047-2022-03057
• 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: 03/29/2022

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-UCT240-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: 01/17/2022
• Initial Date FDA Received: 02/16/2022
• Supplement Dates Manufacturer Received: 02/28/2022
• Supplement Dates FDA Received: 03/29/2022
• 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
• Patient Sequence Number: 1
• Treatment: FB-39Q, JF-260V, TJF-260V, UM-G20-29R
• Patient Outcome(s): Other