MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RADIAL JAW 4; FORCEPS, BIOPSY, NON-ELECTRIC

Model Number	M00513381
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559)
Date of Event	01/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 standard capacity biopsy forceps was used during a gastric biopsy procedure performed on (b)(6) 2022.During the procedure, the forceps did not cut properly and caused a hemorrhage.Four clips were placed and the patient was admitted to the hospital overnight for monitoring.The patient's current condition was reported to be stable.
Additional Manufacturer Narrative
(b)(4).The returned radial jaw 4 standard capacity biopsy forceps was analyzed, and a visual evaluation noted that there were no issues found on the device.A functional evaluation was performed and noted that the device was able to open/close as intended.The reported event was not confirmed.It was reported that the failure mode was observed "during procedure", so it is possible that due to the technique used by the physician in conjunction with the patient anatomy could have affected the device operation.There is not enough evidence to determine whether the inadequate tissue acquisition was due to some issue in the device.The analysis did not find issues or evidence that would confirm that the device had influence on the event.However, the instructions for use (ifu) cited that: "complications associated with the use of the single-use biopsy forceps may include: bleeding".The product record review confirmed that this is not a new failure type and the risk is anticipated.There is no evidence of a manufacturing issue, design or user issue which could have caused the complaint.Therefore, the most probable root cause for the reported patient codes of "hemorrhage, major" and "tissue damage" are assigned as "known inherent risk of device".A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• Brand Name: RADIAL JAW 4
• Common Device Name: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13598615
• Report Number: 3005099803-2022-00909
• Device Sequence Number: 20295568
• Product Code: FCL
• UDI-Device Identifier: 08714729777953
• UDI-Public: 08714729777953
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 02/25/2022

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 Expiration Date: 07/15/2024
• Device Model Number: M00513381
• Device Catalogue Number: 1338
• Device Lot Number: 0027680618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2021
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown