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

Model Number	FB-211D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Pneumothorax (2012)
Date of Event	09/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reports, just after a fiberoscopy for lung biopsy using a disposable biopsy forceps, the patient experienced severe deterioration of the patient's health condition characterized by chest pain followed by vagal discomfort resulting in hypotension (blood pressure 70/50) and bradycardia (heart rate 40bpm).A chest x-ray was taken and showed.Non-compressive left pneumothorax.The patient necessitated 24-hour hospitalization for pain management (morphine administration) and monitoring.No additional consequences to the patient were reported.The suspect device cannot be returned to olympus foe evaluation (it was retained by the facility).
Additional Manufacturer Narrative
The device referenced in this report was not returned to olympus for 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.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the reported event could not be determined.Since there were no reports of defects in the product and there were no problems in the manufacturing records, it is believed that there is no product problem.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿do not insert the instrument into the endoscope unless you have a clear endoscopic field of view.If you cannot see the distal end of the insertion portion in the endoscopic field of view or in x ray images, do not use it.Doing so could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It may also damage the endoscope and/or instrument.¿ ¿do not angulate the endoscope¿s bending section (or operate the forceps elevator, if applicable) abruptly while the distal end of the insertion portion is extended from the distal end of the endoscope.Doing so could cause patient injury, such as perforation, bleeding, or mucous membrane damage.¿ ¿do not insert the instrument into the endoscope while the cups are open.Otherwise, patient injury, such as perforation, bleeding, or mucous membrane damage could occur.It could also damage the endoscope and/or instrument.¿ ¿do not force the distal end of the insertion portion against body cavity tissue.Doing so could cause patient injury, such as perforation, bleeding, or mucous membrane damage.¿ ¿if you press the instrument¿s distal end too hard against the tissue in an attempt to take a sample more than needed, the risk of perforation increase.Do not take more than needed.¿ olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide further legal manufacturer's findings.Based on the findings, it is likely that the reported issue was caused by an accidental injury from a surgical procedure using the device in question, and the event occurred after the physician considered the clinical risk.As previously stated, no malfunction of the device has been reported.Therefore, the use of this device for this application is not restricted.This supplemental report includes a correction to e1.Olympus will continue to monitor field performance for this device.

• 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 Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15674315
• Report Number: 9614641-2022-00537
• Device Sequence Number: 6443907
• Product Code: EOQ
• UDI-Device Identifier: 04953170158124
• UDI-Public: 04953170158124
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K950636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2023

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-211D
• Device Lot Number: 0ZV
• 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: 09/29/2022
• Supplement Date Received by Manufacturer: 12/02/2022; 02/01/2023
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 12/15/2022; 02/10/2023
• 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: Required Intervention; Hospitalization; Other
• Patient Sex: Unknown