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

Model Number	FB-45Q-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pancreatitis (4481)
Date of Event	05/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Average age/years for patients 73 (33-91).Gender: male (75) and female (48).The suspect device has not been returned to olympus for evaluation and 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 received the following literature article: diagnostic performance of a new endoscopic scraper for malignant biliary strictures: a multicenter prospective study by y.Sakuma, et al.This multicenter single-arm prospective study was aimed to investigate the diagnostic performance of a newly developed endoscopic device with ¿scraping loops¿ in combination with conventional biopsy forceps.One hundred and twenty-three (123) patients with suspected malignant biliary strictures were included.The study reported that 83.7% (103/123), 93.5% (115/123), and 95.9% (118/123) of patients were using biopsy forceps, the new device, and their combination, respectively.Complications such as post-ercp pancreatitis (pep) occurred.All the cases of pep occurred in patients without endoscopic sphincterotomy (est).Est was performed in 49 (39.8%) patients.The pep was considered mild in 10 (8.1%) patients, moderate in 0 (0%), and severe in 1 (0.8%).Other adverse events or subsequent deaths were not observed.In conclusion, the study demonstrated that the new endoscopic scraper showed better performance concerning tumor accessibility, larger sample yield, and higher cancer detectability than conventional biopsy forceps in diagnosing malignant biliary strictures.The authors used one-side-open forceps (fb-45q-1, olympus, (b)(4)) or other types of forceps (e.G., radial jaw 4p, boston scientific, (b)(4), usa) for biopsy.The authors didn't specify which device was used in relation to the events reported and will be reported for olympus one-side-open forceps (fb-45q-1).The adverse events reported in the study: post-ercp pancreatitis (pep), mild - (10).Post-ercp pancreatitis (pep), severe - (1).
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: 13509354
• Report Number: 8010047-2022-02770
• Device Sequence Number: 4040212
• Product Code: FCL
• UDI-Device Identifier: 04953170030710
• UDI-Public: 04953170030710
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: CLASS1-EXMPT
• 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): 06/08/2022

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-45Q-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: 05/19/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 06/08/2022
• 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: 0.025-INCH GUIDEWIRES, UNKNOWN; CANNULA, UNKNOWN; METALLIC STENT, UNKNOWN; SINGLE-USE RADIAL JAW 4 BIOPSY FORCEPS; TREFLE ENDOSCOPIC SCRAPER, PIOLAX
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown