MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. PJF-160; DUODENO VIDEOSCOPE

Model Number	PJF-160
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled "conjugated hyperbilirubinemia in infants: is there still a role for ercp?".The literature reported the result of 255 patients (infants aged up to 1 year) with suspicion of biliary obstruction who underwent endoscopic retrograde cholangiopancreatography (ercp) procedure using olympus pediatric duodenoscope pjf and another device.In the literature, the following complications have been reported to have occurred.Asymptomatic hyperamylasemia (12.9%).Suspicion of perforation (1 case).Retroperitoneal depot of the contrast medium (1 case).The literature states as follows, "the overall complication rate was 13.7% of ercp procedures.Asymptomatic hyperamylasemia occurred in 12.9%.It is questionable if asymptomatic hyperamylasemia should be included in the complication rate.The suspicion of perforation (abdominal pain and elevation of crp) occurred in one cholestatic infant with a choledochal cyst after an unsuccessful biliary stent insertion.The problem was resolved conservatively with parenteral nutrition and intravenous antibiotic therapy.In one case, a retroperitoneal depot of the contrast medium emerged during the procedure.It was resolved conservatively (parenteral nutrition and antibiotic therapy).There were no cases of ercp-induced pancreatitis.No mortality was observed after ercp." there are not mentioned that these complications were related to the subject device in question.Based on the available information, specific information on the subject device and the patients were not provided.There is no description of the device's malfunction.However, omsc assumes that "suspicion of perforation" and "retroperitoneal depot of the contrast medium" might be related to the subject device, and the subject device might be caused or contributed to a death or serious injury because the complications suggesting fasting treatment and hospitalization was prolonged.Therefore, omsc determined that the complications were adverse events to submit.Omsc will submit a medical device report (mdr) depending on the complications.
Additional Manufacturer Narrative
The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the serial number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices that passed the inspection.In the literature, there is no description of the device's malfunction.

• Brand Name: PJF-160
• Common Device Name: 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: 13331537
• Report Number: 8010047-2022-01844
• Device Sequence Number: 14663153
• Product Code: FDT
• UDI-Device Identifier: 04953170433498
• UDI-Public: 04953170433498
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K954451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/24/2022

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 Model Number: PJF-160
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown