MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT260

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

Patient Problem Pancreatitis (4481)

Event Date 09/29/2021

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 "efficacy of endoscopic samplings during initial biliary drainage for cases of pancreatic head cancer: united diagnostic yields of multiple pathological samplings" by hiroyuki matsubayashi et al.Abstract: background/objectives: the diagnostic ability of endoscopic ultrasound-guided fine needle aspiration (eus-fna) has been fully studied; however, the efficacy of other endoscopic samplings (oess) is less clear.The aim of this study was to examine the diagnostic efficacies of oess for pancreatic head cancer (phc).Methods: the diagnostic efficacies of endoscopic samplings were retrospectively analyzed in 448 phc cases and 63 cases of mass-forming pancreatitis (mfp) during initial transpapillary biliary drainage.The oess included duodenal biopsy (118 phcs and 50 mfps), biliary biopsy (218 and 51) with cytology (368 and 53), and pancreatic duct biopsy (23 and 13) with cytology (56 and 43).Eus-fna was conducted in a different session (149 and 62).Factors associated with oes sensitivity were analyzed.The sensitivity of biliary biopsy was compared between 1.95 mm and 1.8 mm forceps.Results: cancer cells were confirmed in 87.9% of the eus-fna samplings and in 64.1% (268/418) obtained by combined oess (average 1.7 oes types per case): 68.6% by duodenal biopsy, 59.6% by biliary biopsy, 32.6% by biliary cytology, 73.9% by pancreatic duct biopsy, and 33.9% by pancreatic duct cytology.No mfp cases revealed cancer by any sampling.Oess did not increase adverse events.Duodenal stenosis, serum bilirubin, tumor size, and pancreatic juice amounts were associated with oes sensitivity.Biliary biopsy had the same sensitivity with different forceps.Conclusion: eus-fna was the most diagnostic protocol; however, oess can be safely applied during the initial biliary drainage to reduce the demand for eus-fna while providing good diagnostic yields.The authors used multiple olympus devices in the procedures and post-ercp pancreatitis occurred 18 patients.All pancreatitis was mild and responded to conservative care.Six reports were created as follows for each of the olympus devices: patient identifier (b)(6); gf-uct260, patient identifier (b)(6); jf260v, patient identifier (b)(6); jf240, patient identifier (b)(6); fb-39q, patient identifier (b)(6); fb-44u (mainly 1.95, and occasionally 1.8, or 1.0 mm forceps), patient identifier (b)(6); bc-23q.This report is 1 of 6 for patient identifier (b)(6) gf-uct260.

Manufacturer Narrative

Event date updated to reflect publication date of source article.

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 ULTRASOUND 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: 13903097
• MDR Text Key: 293527293
• Report Number: 8010047-2022-05021
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: GF-UCT260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/24/2022
• Initial Date FDA Received: 03/25/2022
• Supplement Dates Manufacturer Received: 04/15/2022; 05/19/2022
• Supplement Dates FDA Received: 05/13/2022; 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
• Treatment: FB-39Q, FB-44U, BC-23Q, UNKNOWN SERIAL/LOT NUMBERS; JF260V , JF240: UNKNOWN SERIAL NUMBERS
• Patient Outcome(s): Other