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

Model Number	M00513441
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	07/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx basket was used during a procedure performed on (b)(6) 2023.During preparation, a piece of metal was noted inside the packaging with the device.Device was not use and another trapezoid rx basket was opened to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a1802 captures the reportable event of foreign object noted inside the packaging with the device.
Additional Manufacturer Narrative
Block h6: imdrf device code a1802 captures the reportable event of foreign object noted inside the packaging with the device.Block h10: visual inspection of the returned device found that it was observed that the pouch was completely closed and has two particles of foreign material inside.The reported complaint is confirmed.Based on all available information, the analysis found two foreign particles in the closed pouch, but they fall within the acceptable limits outlined in the document 'boxing and box label application 92021606 rev.T.'.The review of the product record affirmed that this is a known issue, and the risk is anticipated.No indications of manufacturing problems or design factors contributing to the event were found.Therefore, the most probable root cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx basket was used during a procedure performed on (b)(6) 2023.During preparation, a piece of metal was noted inside the packaging with the device.Device was not use and another trapezoid rx basket was opened to complete the procedure.There were no patient complications as a result of this event.

• 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: 17407209
• Report Number: 3005099803-2023-04004
• Device Sequence Number: 7357800
• Product Code: FCL
• UDI-Device Identifier: 08714729789918
• UDI-Public: 08714729789918
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/01/2023

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: 01/05/2026
• Device Model Number: M00513441
• Device Catalogue Number: 1344
• Device Lot Number: 0030799096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2023
• 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