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

Model Number	M00513402
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 sc biopsy forceps was used in the colon during a colonoscopy procedure performed on (b)(6) 2022.During the procedure, a metal splinter was noted when the jaws of the forceps came out of the working channel.A photo provided by the customer confirmed this event.The biopsy forceps was removed and another radial jaw 4 sc was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a180104 captures the reportable event of device contamination with chemical or other material.Block h10: the returned radial jaw 4 sc device was analyzed, and a visual inspection observed that the clevis was bent.Under magnification of the microscope, there were no foreign materials present on the returned device.The picture provided by the customer shows the biopsy forceps inside of the patient with an object like a "small stick" inside between the closed jaws.However, it is not possible to determine with the picture what kind of object it can be.The reported event was not confirmed.Based on all available information, no evidence of any foreign material was found on the returned device.In the image provided by the customer it is possible to observe an object like a "small stick", however, this object cannot be defined or identified.Therefore, the investigation conclusion is no problem detected since the device complaint or problem cannot be confirmed.The clevis bent could have occurred because of manipulation or technique used during the procedure since there is no previous reported information about this issue.Therefore, the most probable root cause of the investigation finding clevis bent is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 sc biopsy forceps was used in the colon during a colonoscopy procedure performed on (b)(6) 2022.During the procedure, a metal splinter was noted when the jaws of the forceps came out of the working channel.A photo provided by the customer confirmed this event.The biopsy forceps was removed and another radial jaw 4 sc was used to complete the procedure.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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15250616
• Report Number: 3005099803-2022-04643
• Device Sequence Number: 5905698
• Product Code: FCL
• UDI-Device Identifier: 08714729778028
• UDI-Public: 08714729778028
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/18/2022

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: 03/23/2025
• Device Model Number: M00513402
• Device Catalogue Number: 51475
• Device Lot Number: 0029102623
• 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: 07/28/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2022
• 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