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

Model Number	FB-19C-1
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pneumothorax (2012)
Type of Reportable Event	Serious Injury
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.

• 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
• MDR Report Key: 12306588
• Report Number: 2951238-2021-00375
• Device Sequence Number: 17417627
• Product Code: EOQ
• UDI-Device Identifier: 04953170029585
• UDI-Public: 04953170029585
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2021
• Report Date (Section F): 07/19/2021

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?: Yes
• Distributor Facility Aware Date: 07/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention