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

Model Number	M00546470
Medical Device Problem Codes	Use of Device Problem (1670); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a spybite biopsy forceps was used in the lungs during a robotic bronchoscopy procedure performed on (b)(6) 2022.During the procedure, the forceps failed to close.The physician managed to pull the forceps out and another spybite biopsy forceps was used to complete the procedure.There were no patient complications reported as a result of this event.Note: it was reported that the spybite biopsy forceps was used in a robotic bronchoscopy procedure.However, according to the instructions for use (ifu) "the spybite biopsy forceps should only be used by or under the supervision of physicians trained in endoscopic biliary and pancreatic ducts exploration.A thorough understanding of the technical principles, clinical applications and risks associated with the exploration of the biliary and pancreatic ducts are necessary before using this device." the device is not indicated for use in the lungs.
Additional Manufacturer Narrative
Block h6: device code a051104 captures the reportable event of jaws failed to close in the lungs.Block h10: the returned spybite biopsy forceps was analyzed, and a visual evaluation noted that the jaws were returned closed and one of the links was returned detached.The handle was inspected, and the half spools snaps were completely closed.Due to the condition of the returned device, the functional inspection could not be performed.No other issues were noted.The reported event was confirmed.Based on all available information, most likely procedural factors such as lesion characteristics, device handling, the physician's technique, and normal procedural difficulties encountered during the procedure could have resulted in the detachment of the links, causing the jaws to not close during the procedure.Therefore, the most probable root cause is adverse event related to procedure.The spybite biopsy forceps should only be used by or under the supervision of physicians trained in endoscopic biliary and pancreatic duct exploration, according to the instructions for use (ifu).Before using this device, a thorough understanding of the technical principles, clinical applications, and risks associated with the exploration of the biliary and pancreatic ducts is required.As a result, the event is classified as "cause traced to intentional off-label, unapproved, or contraindicated use" because the problems are traced to the device's intentional use in an unapproved procedure, for an unapproved patient, or for which it is contraindicated or not listed on the label.A labeling review was performed and there is evidence that the device was used not in accordance with the instructions for use (ifu) / product label, as the device was used in the lungs.
Event or Problem Description
It was reported to boston scientific corporation that a spybite biopsy forceps was used in the lungs during a robotic bronchoscopy procedure performed on (b)(6) 2022.During the procedure, the forceps failed to close.The physician managed to pull the forceps out and another spybite biopsy forceps was used to complete the procedure.There were no patient complications reported as a result of this event.Note: it was reported that the spybite biopsy forceps was used in a robotic bronchoscopy procedure.However, according to the instructions for use (ifu) "the spybite biopsy forceps should only be used by or under the supervision of physicians trained in endoscopic biliary and pancreatic ducts exploration.A thorough understanding of the technical principles, clinical applications and risks associated with the exploration of the biliary and pancreatic ducts are necessary before using this device." the device is not indicated for use in the lungs.

• Brand Name: SPYBITE MAX
• Common Device Name: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• 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: 15850067
• Report Number: 3005099803-2022-06818
• Device Sequence Number: 15084268
• Product Code: FCL
• UDI-Device Identifier: 08714729996699
• UDI-Public: 08714729996699
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2023

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: 07/26/2025
• Device Model Number: M00546470
• Device Catalogue Number: 4647
• Device Lot Number: 0029843184
• 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: 10/31/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2022
• 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