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

Model Number	M00546470
Medical Device Problem Codes	Break (1069); 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	11/30/2022
Type of Reportable Event	Malfunction
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, and the pull wire protruded out the center.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
(b)(4).
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable event of pull wire break.Device code a051104 captures the reportable event of jaws failure to close.Block h10: the returned spybite biopsy forceps was analyzed, and a visual evaluation observed that one of the links was returned detached.A functional inspection was performed by attempting to open and close the jaws; however, the jaws did not open.No other issues with the device were noted.The reported event of jaws failure to close 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, and normal procedural difficulties encountered during the procedure 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.For the as reported pull wire break event cannot be confirmed, because no damaged was noted.The device is not indicated for use in the lungs, for this reason the event is catalogued as "cause traced to intentional off-label, unapproved, or contraindicated use" because the problems traced to the intentional use of the device in an unapproved procedure, for an unapproved patient, or for which it is contraindicated, or not listed on the label.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Block h11: correction: h6 device code a23 added to capture misuse as the device is not indicated for use 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, and the pull wire protruded out the center.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; 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: 16042142
• Report Number: 3005099803-2022-07595
• Device Sequence Number: 12328775
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2023

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): Initial
• Initial Date Received by Manufacturer: 11/30/2022
• Supplement Date Received by Manufacturer: 01/15/2023
• Initial Report FDA Received Date: 12/23/2022
• Supplement Report FDA Received Date: 02/09/2023
• 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