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	Unspecified Hepatic or Biliary Problem (4493)
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: "tissue acquisition for diagnosis of biliary strictures using peroral cholangioscopy or endoscopic ultrasound-guided fine-needle aspiration" by yun nah lee, jong ho moon, et al.  this prospective single-center observational study aimed to evaluate the usefulness of a diagnostic approach using peroral cholangioscopy forceps biopsy (poc-fb) or endoscopic ultrasound-guided fine-needle aspiration biopsy (eus-fnab) according to the stricture location in patients with suspected mbs.Among a total of 181 patients, initial tpb showed malignancy in 122 patients, and the diagnostic accuracy of initial tpb was 71.8% (95% confidence interval [ci] 65.3%¿78.4 %].Of the 59 patients in whom tpb was negative for malignancy, 32 had proximal biliary strictures and underwent successful poc.The remaining 27 patients had distal strictures and underwent successful eus-fnab.The accuracy of malignancy detection using poc-fb for proximal biliary strictures and eus-fnab for distal biliary strictures was 93.6% (95%ci 84.9%-100%) and 96.3% (95%ci 89.2%-100 %), respectively.The overall diagnostic accuracy for the combination of tpb with either poc-fb for proximal strictures and eus-fnab for distal strictures was 98.3% (95 %ci 95.9%-100 %) and 98.4% (95%ci 95.3%-100 %), respectively.An approach using poc-fb or eus-fnab according to the stricture location may be useful in the diagnosis of suspected mbs.  the authors used 3 olympus devices and did not specify which device may have been involved with the reported cholangitis (2 patients from poc group).This article includes 3 reports: (b)(6), model: fb39q - lot: unknown- ae: cholangitis.(b)(6), model: gif-xp260ns- sn: unknown- ae: cholangitis.(b)(6), model: gif-xp260n- sn: unknown- ae: cholangitis.This report is 1 of 3 for (b)(6), model: fb39q - lot: unknown- ae: cholangitis.
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.The case is not due to design.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There is no evidence of an olympus device malfunction.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): 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: 13536568
• Report Number: 8010047-2022-02979
• Device Sequence Number: 17402910
• Product Code: FCL
• UDI-Device Identifier: 04953170030659
• UDI-Public: 04953170030659
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 03/15/2022

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: 01/17/2022
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 03/15/2022
• 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: GIF-XP260NS OR GIF-XP260N
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown