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

Model Number	M00513401
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	01/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a radial jaw 4 standard capacity biopsy forceps was used in the duodenum during a gastroscopy procedure performed on (b)(6) 2024.During the procedure, the radial jaw 4 took too large of a biopsy.The procedure was completed with the same device.After 48 hours, the patient was re-hospitalized for gastroscopy due to bleeding.The bleeding was treated with a clip.Patient has fully recovered.
Additional Manufacturer Narrative
Block h2: correction: block h6 impact codes has been corrected.Imdrf impact code f2301 was added to capture the use of a clip to treat the bleeding.Block h6: imdrf patient code e0506 captures the reportable patient complication of major hemorrhage.Imdrf impact code f2022 captures the endoscopy procedure of gastroscopy.Imdrf impact code f08 captures the prolonged hospitalization of the patient.Imdrf impact code f2301 captures the event that bleeding was treated with a clip.
Event or Problem Description
It was reported that a radial jaw 4 standard capacity biopsy forceps was used in the duodenum during a gastroscopy procedure performed on (b)(6) 2024.During the procedure, the radial jaw 4 took too large of a biopsy.Sufficient biopsy samples were taken, and the procedure was completed with the same device.The patient was hospitalized beyond the standard of care and a repeat gastroscopy was performed 48 hours later to control bleeding at the site of the initial biopsy.The bleeding was treated with a clip.Patient has fully recovered.
Additional Manufacturer Narrative
Block h6: imdrf patient code e0506 captures the reportable patient complication of major hemorrhage.Imdrf impact code f2022 captures the endoscopy procedure of gastroscopy.Imdrf impact code f08 captures the prolonged hospitalization of the patient.

• 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: 18717165
• Report Number: 3005099803-2024-00198
• Device Sequence Number: 16970856
• Product Code: FCL
• UDI-Device Identifier: 08714729777960
• UDI-Public: 08714729777960
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

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: 10/02/2026
• Device Model Number: M00513401
• Device Catalogue Number: 1340
• Device Lot Number: 0032561637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2023
• 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
• Patient Sex: Unknown