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

Model Number	M00513391
Medical Device Problem Codes	Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
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 used in the esophagus during a biopsy procedure performed on (b)96) 2024.During the procedure, the forceps could not be removed from the forceps channel after esophageal biopsy.The user tried to push towards the tip, but it could not be pushed out.The procedure was canceled as the endoscope became unusable.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter city (b)(6).Block h6: imdrf impact code f1001 captures the reportable event of procedure cancelled.
Additional Manufacturer Narrative
Block e1: initial reporter city (b)(6).Block h6: imdrf impact code f1001 captures the reportable event of procedure cancelled.Block h11: the radial jaw 4 standard capacity biopsy forceps was returned for analysis.Visual examination of the returned device found a small segment of the jacket returned kinked and cut.The reported event was not confirmed.There is not enough evidence to determine whether the device entrapment and cancelled procedure was due to the physician's technique during the procedure or was related to a device malfunction.The most probable root cause is cause not established as the analysis of the available information did not determine a more specific complaint cause.The returned segment was kinked and cut, but it is not clear if these damages were related to the entrapment or the removal of the scope.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 standard capacity biopsy forceps was used in the esophagus during a biopsy procedure performed on (b)(6) 2024.During the procedure, the forceps could not be removed from the forceps channel after esophageal biopsy.The user tried to push towards the tip, but it could not be pushed out.The procedure was canceled as the endoscope became unusable.There were no patient complications reported 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: 19341832
• Report Number: 3005099803-2024-02137
• Device Sequence Number: 21017700
• Product Code: FCL
• UDI-Device Identifier: 08714729777977
• UDI-Public: 08714729777977
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/26/2024

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 Model Number: M00513391
• Device Catalogue Number: 1339
• Device Lot Number: 0032729825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 07/05/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2023
• 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