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

Model Number	M00513412
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: date of event was approximated to 09/01/2024 (first day of the month) as no event date was reported.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf patient code e0506 captures the reportable event of severe bleeding with hemoglobin drops.Imdrf impact code f08 captures the reportable event of hospitalization.
Event or Problem Description
It was reported to boston scientific corporation that an unknown number of radial jaw 4 standard capacity biopsy forceps were used during gastric biopsy procedures performed over the past 6 months to one year.Complications varying from mild bleeding with melaena to severe bleeding with hemoglobin drops and hospitalization occurred 24 to 48 hours post procedure.In certain cases, where the bleeding was observed immediately, clips were placed.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block b3: date of event: date of event was approximated to 09/01/2024 (first day of the month) as no event date was reported.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf patient code e0506 captures the reportable event of severe bleeding with hemoglobin drops.Imdrf impact code f08 captures the reportable event of hospitalization.Blocks b2, b5, and h6 impact codes have been updated based on the additional information that was received on october 24, 2024.
Event or Problem Description
It was reported to boston scientific corporation that an unknown number of radial jaw 4 standard capacity biopsy forceps were used during gastric biopsy procedures performed over the past 6 months to one year.Complications varying from mild bleeding with melaena to severe bleeding with hemoglobin drops and hospitalization occurred 24 to 48 hours post procedure.In certain cases, where the bleeding was observed immediately, clips were placed.No further information has been obtained despite good faith efforts.Additional information received on october 24, 2024.One patient with severe hb drop was admitted to hospital and blood transfusion was needed.The occurrence in anatomy locations vary from stomach to colon.

• 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; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20360412
• Report Number: 3005099803-2024-04865
• Device Sequence Number: 7171389
• Product Code: FCL
• UDI-Device Identifier: 08714729778004
• UDI-Public: 08714729778004
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 11/14/2024

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 Model Number: M00513412
• Device Catalogue Number: 51309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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