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

Model Number	M00513401
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 standard capacity biopsy forceps was to be used during a procedure on (b)(6) 2023.Prior to the procedure when preparing the medical supplies for the endoscopy room, a hair was observed inside the product packaging.There was no patient involvement reported for this event as this happened prior to the procedure.
Additional Manufacturer Narrative
Block h6: imdrf device code a1802 captures the reportable event of packaging foreign matter.
Additional Manufacturer Narrative
Block h6: imdrf device code a1802 captures the reportable event of packaging foreign matter.Block h10: the radial jaw 4 multibite single-use biopsy forceps was returned to boston scientific for laboratory analysis.Visual inspection confirmed the presence of a hair inside the sealed pouch.Following receipt of this complaint event and returned product analysis, boston scientific initiated a non-conforming events prevention (ncep) investigation to determine if any corrective actions were warranted.Boston scientific's investigation concluded that the referenced event was an isolated event due to human error.A review of the manufacturing process found that the pouch inspection operation step to ensure that packaged devices are free of foreign material was not completed in this case.All product builders were made aware of the event, and the procedure was reviewed by all applicable product builders to heighten awareness of the requirements outlined in this manufacturing process, including the pouch inspection procedure.The ncep investigation was completed on october 20, 2023.Boston scientific's product performance monitoring confirms that the radial jaw 4 multibite single-use biopsy forceps is performing within established design, safety, and anticipated product performance expectations, and continues to meet its intended use with respect to safety and performance.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 standard capacity biopsy forceps was to be used during a procedure on (b)(6), 2023.Prior to the procedure when preparing the medical supplies for the endoscopy room, a hair was observed inside the product packaging.There was no patient involvement reported for this event as this happened prior to the procedure.

• 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: 17695268
• Report Number: 3005099803-2023-04722
• Device Sequence Number: 2647534
• Product Code: FCL
• UDI-Device Identifier: 08714729777960
• UDI-Public: 08714729777960
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/11/2026
• Device Model Number: M00513401
• Device Catalogue Number: 1340
• Device Lot Number: 0031411775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2023
• 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
• Patient Sex: Unknown