MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. BIOPSY FORCEPS

Model Number	FB-39Q-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pancreatitis (4481); Cholangitis (4821)
Date of Event	04/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is related to the following linked patient identifiers: (b)(6).The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
Olympus reviewed the following literature titled "impact of a new dedicated sheath device for tissue sampling of biliary stricture on pathological diagnostic yield: retrospective study".Background and study aims.Endoscopic transpapillary biliary forceps biopsy (tbfb) is a common method for obtaining specimens from biliary lesions.Its diagnostic yield is unsatisfactory; to overcome this disadvantage, a dedicated sheath has been developed.This study aimed to evaluate the outcomes of conventional tbfb and tbfb with a novel sheath device.Patients and methods: consecutive patients who underwent tbfb between (b)(6) 2020 and (b)(6) 2021 were retrospectively evaluated.The rate of obtaining adequate samples, failed attempts at forceps insertion into the bile duct, and sensitivity were compared between the two groups.Results: ninety-two patients who underwent 115 endoscopic retrograde: cholangiopancreatographies (76 in the conventional group vs.39 in the dedicated sheath group) were included.The rates of obtaining adequate samples, failed attempts of the forceps into the bile duct, and sensitivity were 72.4% vs.89.7% (p = 0.03), 28.3% vs.0% (p < 0.01), and 66.7% vs.88.9% (p =0.02), respectively.Conclusions: tbfb with the novel sheath device contributed to improved sensitivity for diagnosis of biliary stricture without insertion of forceps outside the bile duct.Type of adverse events/number of patients.Pancreatitis 3 patients.Cholangitis 1 patient.
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: BIOPSY FORCEPS
• Common Device Name: BIOPSY FORCEPS
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19562743
• Report Number: 9614641-2024-01274
• Device Sequence Number: 7606497
• 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: Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2024

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: FB-39Q-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: 05/21/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 06/28/2024
• 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: Other
• Patient Sex: Unknown