MAUDE Adverse Event Report: BIOPSY FORCEPS

Model Number	FB-19C-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pneumothorax (2012)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report has not been returned to olympus for physical evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This event has been reported by the importer on mdr# 2951238-2021-00375.
Event or Problem Description
In the literature titled: "transbronchial biopsy and cryobiopsy in the diagnosis of hypersensitivity pneumonitis among patients with interstitial lung disease", it is reported six percent of the patients undergoing a transbronchial forceps lung biopsy (tbbx) experienced pneumothorax requiring chest tube placement, and 34.2% of patients experienced moderate bleeding (no information about treatment provided).This systematic review and meta-analysis was performed to assess the efficacy as diagnostic yield and safety as the complication rates of two different sampling techniques viz., transbronchial forceps lung biopsy (tbbx) and transbronchial lung cryobiopsy (tblc) in the diagnosis of hypersensitivity pneumonitis (hp) with interstitial lung disease (ild).Throughout the october 2019 medline, embase and the cochrane library were searched and included the studies that enrolled patients with ild and reported the diagnostic yields and complication rates for tbbx or tblc.A meta-analysis of the data extracted from the included articles showed both tblc and tbbx was complicated by pneumothorax, mild to moderate and severe bleeding events.However, study concluded tblc was found to be more reliable for diagnostic yield but with higher complications rates than tbbx.In this study it mentions that some tbbx case may have used an olympus fb-19c-1 biopsy forceps.There is no specific data provided regarding how many of the tbbx cases in this meta-analysis used an olympus device or if in any (or how many) of the tbbx cases that did use an olympus device, the patient experienced either moderate bleeding or pneumothorax.For this reason, one report is being to report the possibility that an olympus biopsy forceps could have been used in a procedure that led to moderate bleeding or pneumothorax (requiring chest tube placement).There is no report of any olympus device malfunction in any procedure reported in the article.
Additional Manufacturer Narrative
This report is being updated to provide investigation findings.The device history record (dhr) for the complaint device could not be reviewed since the lot number was not provided.Olympus does not ship any device that does not meet all design and safety specifications.The suspect device was not returned to olympus, therefore an evaluation/inspection could not be conducted.Conclusion: the definitive cause of the reported events could not be established.There was no report of any olympus device malfunction reported in any procedure described in this study, therefore it is presumed that the cause of the reported events is not related to the device.

• Brand Name: BIOPSY FORCEPS
• Common Device Name: BIOPSY FORCEPS
• MDR Report Key: 12306605
• Report Number: 8010047-2021-10086
• Device Sequence Number: 5002350
• Product Code: EOQ
• UDI-Device Identifier: 04953170029585
• UDI-Public: 04953170029585
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K962555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,literatur
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2021

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-19C-1
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 10/08/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention