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

Model Number	FB-231D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Hypoxia (1918); Pneumothorax (2012); Unspecified Respiratory Problem (4464); Genital Bleeding (4507)
Date of Event	10/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the literature described "forceps which were 1.9 mm in diameter", we selected "fb-231d" as a representative product.The product was unknown but a representative product was chosen for processing purposes.The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
[auto-translated] olympus medical systems corp.(omsc) received a literature titled "diagnostic yield and safety of cp-ebus-tbna and rp-ebus-tblb under moderate sedation: a single-center retrospective audit".Literature summary: this retrospective review study aimed to describe the diagnostic yield and safety of cp-ebus-tbnas and rp-ebus-tblbs when performed under moderate sedation in 421 patients.The diagnostic yield of the cp-ebus-tbnas and rp-ebus-tblbs were 62.5% and 71.6%, respectively.The most frequent diagnosis for cp-ebus-tbnas were malignancy, sarcoidosis, and mycobacterium infection (50.9%, 6.3%, and 4.2%, respectively).The most frequent diagnoses for rp-ebus - tblbs were malignancy, organizing pneumonia, and mycobacterium infection (45.8%, 10% and 3.7%, respectively) this study concludes that performing cp-ebus-tbnas and rp-ebus-tblbs under moderate sedation is safe and provides good diagnostic yield.Type of adverse events/number of patients bleeding - 50 patients.Pneumothorax - 1 patient.Hypoxia - 2 patients.Respiratory complaints or fever - 10 patients.Since the literature described "bf-uc260f was connected to eu-me1, we selected "bf-uc260fw" as a representative product.The product was unknown but a representative product was chosen for processing purposes.Since the literature described "bf-q290, bf-260 was connected to cv-260sl or cv-290", we selected "bf-q290, bf-260" as a representative product.Since the literature described "forceps which were 1.9 mm in diameter", we selected "fb-231d" as a representative product.The product was unknown but a representative product was chosen for processing purposes.1.(b)(6)/na-201sx-4022.2.(b)(6)/bf-uc260fw.3.(b)(6)/fb-231d.4.(b)(6)/bf-q290.5.(b)(6)/bf-260.6.(b)(6)/um-s20-17s.This complaint is (b)(6).
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.
Event or Problem Description
Additional information received from the author confirming there was no malfunction of the olympus equipment and the reported complications are comparable to reported complications in literature.

• Brand Name: DISPOSABLE BIOPSY FORCEPS
• Common Device Name: DISPOSABLE 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: 16159368
• Report Number: 9614641-2023-00054
• Device Sequence Number: 7507506
• Product Code: EOQ
• UDI-Device Identifier: 04953170158209
• UDI-Public: 04953170158209
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K950636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2023

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-231D
• 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: 12/18/2022
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown