MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. G653021 REPAIR FOR PJF-240 (S/N:280T023); DUODENO VIDEOSCOPE

Model Number PJF-240

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

Patient Problem Pancreatitis (4481)

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user¿s experience cannot be determined at this time.The investigation is ongoing this report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported in the literature titled "review of pediatric ercp at our hospital," patients experience post-procedure pancreatitis after endoscopic retrograde cholangiopancreatography (ercp) using one of two types of olympus duodenoscopes.Case with patient identifier (b)(6) reports pjf-240.Case with patient identifier (b)(6) reports jf-260v.Background: ercp for children is described in pediatric gastroenterological endoscopy guidelines.However, due to the variety of diseases and treatments, the guidelines do not provide detailed information.Therefore, the indications for ercp for children may vary from facility to facility.Study goal: to understand the current status of pediatric ercp cases at our hospital and examine their safety.Method: from december 2013 to september 2021, we retrospectively examined 23 cases of 11 children (10 patients of ercp and 5 patients of db-ercp) who tried ercp at our hospital.The items to be examined were 1) patient background, 2) treatment details, and 3) comorbidities.Results: 1) the median age of the target patients at the time of initial ercp was 7 years (0-14 years).The patients were 7 boys and 4 girls.The breakdown of the disease was bile duct stone in 3 cases, pancreatobiliary maljunction in 3 cases, pancreatic duct union failure in 2 cases, anastomotic stenosis in 2 cases, recurrent pancreatitis in 2 cases, annular pancreas in 1 case, and traumatic pancreatic injury in 1 case.2) in 21 patients, intravenous anesthesia was performed, and in 2 patients, general anesthesia was performed.As for the scope, the adult scope (jf260v) was used in 22 patients, and pjf-240 was used in 1 patient.The purpose of ercp was for diagnosis in 2 patients (both pancreatic ducts) and for treatment in 21 patients (for bile ducts in 10 patients and for pancreatic ducts in 11 patients).The treatment success rate was 22/23 (95.7%).The median procedure time was 39 minutes (3-151 minutes).One case of unsuccessful procedure was an annular pancreas case, and eus-pd was performed as an alternative method.3) there were only 2 cases of post-ercp pancreatitis in 1 patient.These two cases were mild.Conclusion: only 0-1 year-old children used pjf-240 with a small diameter, and jf260v could be used for 2 years and older.There is no report of olympus device malfunction in any procedure described in this study.

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: G653021 REPAIR FOR PJF-240 (S/N:280T023)
• Type of Device: DUODENO 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: 14787632
• MDR Text Key: 295040028
• Report Number: 8010047-2022-10646
• Device Sequence Number: 1
• Product Code: FDT
• 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,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PJF-240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2022
• 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