MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. BIOPSY FORCEPS

Model Number	FB-19C-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pancreatitis (4481)
Date of Event	10/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On november 22, 2021, olympus medical systems corp.(omsc) received the literature titled "comparison of eus and ercp-guided tissue sampling in suspected biliary stricture".The purpose of this literature was to compare the diagnostic yield of endoscopic ultrasound(eus) and endoscopic retrograde cholangiopancreatography(ercp)-based tissue sampling in biliary strictures not accompanied by mass in adjacent organs.In the literature, it was reported as follows; demographic and clinical characteristics for the 85 patients analyzed in the study.Stricture alone was observed in 77.6% (66/85) of patients and stricture accompanying mass within the bile duct was identified in 19 (22.4%) patients on ct and/or mri.For ercp, a duodenoscope (tjf-260; olympus) was used.After cannulation and cholangiography, sphincterotomy or balloon dilatation was performed in most cases.The brush (rx cytology brush wireguided cytology brush, boston scientific) was inserted into the bile duct over the guidewire (0.025- or 0.035-inch visiglide; olympus).Brushing cytology was obtained with more than 10 to-and-fro brushing strokes passing the biliary stricture.The brush was smeared onto the slide, which was fixed in alcohol and transferred to the pathology department.Intraductal biopsy was done with forceps (single-use radial jaw¿ 4 biopsy forceps, boston scientific or reusable biopsy forceps, olympus) directly through the ampulla of vater (aov) with fluoroscopic guidance.Procedure-related adverse events were documented in 14 patients, all of which were post-procedure acute pancreatitis managed with intravenous hydration and fasting for 1¿2 days.There were no cases of bleeding or bowel perforation.Omsc assumes that acute pancreatitis cannot be denied a relationship with the subject device due to the intraductal biopsy procedure used by the subject device.And, omsc assumes that acute pancreatitis was a serious injury that might be caused or contributed to a death or serious injury.Since acute pancreatitis is managed with intravenous hydration and fasting for 1¿2 days.Therefore, omsc assumes that the acute pancreatitis was an adverse event to submit.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.Therefore, omsc will submit a medical device report (mdr) for acute pancreatitis managed with intravenous hydration and fasting for 1¿2 days.
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.
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 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: BIOPSY FORCEPS
• Common Device Name: BIOPSY FORCEPS
• 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: 12826215
• Report Number: 8010047-2021-14666
• Device Sequence Number: 4571212
• Product Code: EOQ
• UDI-Device Identifier: 04953170029585
• UDI-Public: 04953170029585
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K962555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2022

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
• Operator of Device: Health Professional
• Device Model Number: FB-19C-1
• 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: 10/22/2021
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 04/19/2022
• 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
• Patient Sex: Unknown