MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS DUODENOVIDEOSCOPE

Model Number	JF-140R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Cyst(s) (1800); Nausea (1970); Vomiting (2144); Pancreatitis (4481)
Date of Event	01/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled "risk factors for post-endoscopic retrograde cholangio-pancreatography pancreatitis in children with chronic pancreatitis and its prediction using 4-hour postprocedure serum amylase and lipase levels".Thirty children with chronic pancreatitis (cp) who underwent 62 endoscopic retrograde cholangio-pancreatography (ercp) procedures were studied.Post¿endoscopic retrograde cholangio-pancreatography pancreatitis (pep) occurred in 14.5% (9/62) of ercp procedures (mild: 8, moderate:1) with no mortality.Type of adverse events/number of patients pep: 9/62 {pancreatic pseudocyst -1, epigastric pain abdomen -9, nonbilious vomiting -5, bulky pancreas -6} 8 mild, 1 moderately severe.Symptoms (abdominal pain, nausea, and vomiting) and signs (abdominal tenderness) of pancreatitis were clinically evaluated for 24 hours after ercp.If the child developed abdominal pain any time after the procedure they were evaluated for cause of pain and started on symptomatic treatment (nothing by mouth, intravenous fluids, and analgesics).The diagnosis of pep was based on new or worsened abdominal pain combined with elevated serum pancreatic enzymes, thus prolonging a planned hospital admission or necessitating hospitalization after an ercp.Any complication was managed as per standard protocol.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional 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 serial and/or 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 events cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS DUODENOVIDEOSCOPE
• Common Device Name: DUODENOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19514969
• Report Number: 9610595-2024-11765
• Device Sequence Number: 12594293
• Product Code: FDT
• UDI-Device Identifier: 04953170339851
• UDI-Public: 04953170339851
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K980465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

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
• Operator of Device: Health Professional
• Device Model Number: JF-140R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown