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

Model Number	FB-39Q-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pancreatitis (4481)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Olympus reviewed the following literature article: "biliary guidewire facilitates bile duct biopsy and endoscopic drainage" by toshihiko higashizawa, et al.The study investigated the introduction of a guidewire through bile duct strictures and across the biliary stenosis to find out if that facilitates the transpapillary bile duct biopsy and subsequent biliary drainage.Transpapillary bile duct biopsy was attempted in 61 consecutive cases, with extrahepatic or intrahepatic bile duct strictures detected by endoscopic retrograde cholangiopancreatography (ercp).The study evaluated the success rate of endoscopic biliary drainage after performing bile duct biopsy and complications.In conclusion, the study said that the patients with bile duct strictures at ercp, the placement of a guidewire facilitates the insertion of biopsy forceps and subsequent endoscopic biliary drainage, and the biopsies were positive for cancer are more likely with bile duct cancer than pancreatic cancer.One patient suffered from acute pancreatitis that resolved within 48 h after treatment with analgesia and intravenous fluids.The authors reported using 3 different olympus devices and did not specify the olympus device used in relation to the adverse event and therefore, all will be reported.(b)(6) is for jf-230; (b)(6) is for jf-200; (b)(6) is for fb-39q-1.This is report 3 of 3 for (b)(6) is for fb-39q-1.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Updated d4, udi.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: 13550110
• Report Number: 8010047-2022-03127
• Device Sequence Number: 5256527
• Product Code: FCL
• UDI-Device Identifier: 04953170030659
• UDI-Public: 04953170030659
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2022

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-39Q-1
• Device Lot Number: UNKNOWN(LITERATURE)
• 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: 01/18/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 04/28/2022
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JF-230 OR JF-200
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown