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	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/11/2022
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 in the colon during a diagnostic colonoscopy procedure performed on (b)(6) 2022.During the procedure, the patient experienced bleeding and a hematoma.A resolution 360 clip was placed to stop the bleeding.The patient was admitted to the hospital and was discharged on an unknown date.No other patient complications were reported.It was reported that the patient fully recovered.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Block e1: initial reporter city is (b)(6).Block h6: patient code e0506 captures the reportable event of hemorrhage, major.Impact code f08 captures the reportable event of the patient was admitted to hospital beyond the standard of care.Block b5 was updated based on additional information received that the patient was admitted for 1 day.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 standard capacity biopsy forceps was used in the colon during a diagnostic colonoscopy procedure performed on (b)(6) 2022.During the procedure, the patient experienced bleeding and a hematoma.A resolution 360 clip was placed to stop the bleeding.The patient was admitted to the hospital for 1 day and was discharged on the same day (b)(6) 2022.No other patient complications were reported.It was reported that the patient fully recovered.

• 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: 15725655
• Report Number: 3005099803-2022-06326
• Device Sequence Number: 2930797
• Product Code: FCL
• UDI-Device Identifier: 08714729777960
• UDI-Public: 08714729777960
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2022

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: 11/09/2024
• Device Model Number: M00513401
• Device Catalogue Number: 1340
• Device Lot Number: 0028364580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2022
• Supplement Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2021
• 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
• Patient Sex: Unknown