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 "efficacy of endoscopic samplings during initial biliary drainage for cases of pancreatic head cancer: united diagnostic yields of multiple pathological samplings" by hiroyuki matsubayashi et al.Abstract: background/objectives: the diagnostic ability of endoscopic ultrasound-guided fine needle aspiration (eus-fna) has been fully studied; however, the efficacy of other endoscopic samplings (oess) is less clear.The aim of this study was to examine the diagnostic efficacies of oess for pancreatic head cancer (phc).Methods: the diagnostic efficacies of endoscopic samplings were retrospectively analyzed in 448 phc cases and 63 cases of mass-forming pancreatitis (mfp) during initial transpapillary biliary drainage.The oess included duodenal biopsy (118 phcs and 50 mfps), biliary biopsy (218 and 51) with cytology (368 and 53), and pancreatic duct biopsy (23 and 13) with cytology (56 and 43).Eus-fna was conducted in a different session (149 and 62).Factors associated with oes sensitivity were analyzed.The sensitivity of biliary biopsy was compared between 1.95 mm and 1.8 mm forceps.Results: cancer cells were confirmed in 87.9% of the eus-fna samplings and in 64.1% (268/418) obtained by combined oess (average 1.7 oes types per case): 68.6% by duodenal biopsy, 59.6% by biliary biopsy, 32.6% by biliary cytology, 73.9% by pancreatic duct biopsy, and 33.9% by pancreatic duct cytology.No mfp cases revealed cancer by any sampling.Oess did not increase adverse events.Duodenal stenosis, serum bilirubin, tumor size, and pancreatic juice amounts were associated with oes sensitivity.Biliary biopsy had the same sensitivity with different forceps.Conclusion: eus-fna was the most diagnostic protocol; however, oess can be safely applied during the initial biliary drainage to reduce the demand for eus-fna while providing good diagnostic yields.The authors used multiple olympus devices in the procedures and post-ercp pancreatitis occurred 18 patients.All pancreatitis was mild and responded to conservative care.Six reports were created as follows for each of the olympus devices: patient identifier (b)(6) - gf-uct260, patient identifier (b)(6) - jf260v, patient identifier (b)(6) - jf240, patient identifier (b)(6) - fb-39q, patient identifier (b)(6) - fb-44u (mainly 1.95, and occasionally 1.8, or 1.0 mm forceps), patient identifier (b)(6) - bc-23q.This report is 4 of 6 for patient identifier (b)(6) - fb-39q.
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: 13919716
• Report Number: 8010047-2022-05025
• Device Sequence Number: 6356873
• 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): 05/03/2022

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: 02/24/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 03/26/2022
• Supplement Report FDA Received Date: 05/04/2022
• 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: FB-44U, BC-23Q, UNKNOWN SERIAL/LOT NUMBERS.; GF-UCT260, JF260V , JF240: UNKNOWN SERIAL NUMBERS.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown