MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYBITE MAX; FORCEPS, BIOPSY, NON-ELECTRIC

Model Number	M00546470
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a spybite max biopsy forceps was used during an e.R.C.P.(endoscopic retrograde cholangiopancreatography) procedure performed on (b)(6) 2023.During preparation, after the patient had been sedated, when device was unpacked, it was noticed that the sheath of the spybite forceps was kinked.However, the procedure was cancelled due to the patient being weak.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
H6: impact code f1001 captures the reportable event of procedure not completed due to the reason of patient being weak.
Additional Manufacturer Narrative
Block h6: impact code f1001 captures the reportable event of procedure not completed due to the reason of patient being weak.Block h10: the returned spybite biopsy forceps was analyzed, and it was observed that the jaws were returned closed, and the jacket was kinked in the distal section.A functional inspection was performed by attempting to open and close the jaws; however, due to the kinks encountered, the jaws did not open.No other issues with the device were noted.The reported event of jacket kinked was confirmed.Based on all available information, it is most likely that procedural factors such as lesion characteristics, handling of the device, the technique used by the physician, could have resulted to the damages encountered on the device; thus, could have affected its performance and its intended purpose, leading to the reported event.Therefore, the most probable root cause is adverse event related to procedure.Device history record review: a review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a spybite max biopsy forceps was used during an e.R.C.P.(endoscopic retrograde cholangiopancreatography) procedure performed on (b)(6) 2023.During preparation, after the patient had been sedated, the device was unpacked, and it was noticed that the sheath of the spybite forceps was kinked.However, the procedure was cancelled due to the patient being weak.There were no patient complications reported as a result of this event.

• Brand Name: SPYBITE MAX
• Common Device Name: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; spencer IN 47460
• 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: 16693742
• Report Number: 3005099803-2023-01726
• Device Sequence Number: 7397549
• Product Code: FCL
• UDI-Device Identifier: 08714729996699
• UDI-Public: 08714729996699
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 05/15/2023

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: 07/21/2025
• Device Model Number: M00546470
• Device Catalogue Number: 4647
• Device Lot Number: 0029815282
• 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: 03/16/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2022
• 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