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

Model Number	M00513401
Medical Device Problem Codes	Entrapment of Device (1212); Material Integrity Problem (2978); Material Twisted/Bent (2981); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.According to the complainant, the suspect device is not available for return.If any further relevant information is received, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 standard capacity biopsy forceps was used in a procedure performed on an unknown date.During the procedure, the biopsy forceps got stuck in the insertion port of the endoscope.Fluoroscopy noted deformation around the base of the cups.The scope could no longer be used; therefore, the procedure was aborted.The endoscope was sent to the manufacturer for investigation, together with the biopsy forceps that could not be removed.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 standard capacity biopsy forceps was used in a procedure performed on an unknown date.During the procedure, the biopsy forceps got stuck in the insertion port of the endoscope.Fluoroscopy noted deformation around the base of the cups.The scope could no longer be used; therefore, the procedure was aborted.The endoscope was sent to the manufacturer for investigation, together with the biopsy forceps that could not be removed.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Additional information received as of december 10, 2021.The procedure was performed on early august.According to the olympus report and photo, the clevis arms is bent.
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h2: additional information: b3 date of event, b5 event description, h6 device code.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: medical device problem code a27 is being used to capture the reportable event of aborted/cancelled procedure.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: according to the complainant, the suspect device is not available for return.If any further relevant information is received, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: medical device problem code a27 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: the returned radial jaw 4 biopsy forceps was analyzed, and a visual evaluation noted that the device was cut off with the jaws inside the scope part.The jacket presents damage from a sharp object and the clevis arms are bent.The reported event was confirmed.Based on all available information, it is possible that due to the manipulation or the technique used by the physician in conjunction with the patient's anatomy at the time to take biopsies could have affected the device operation.An excess of force could have been applied bending the clevis arms, then at the time of trying to remove the device, the arms bent even more, resulting in the inability to pass backwards.The evidence of the scope part and the device cut off indicates complications to remove the device.Therefore, the most probable root cause is adverse event related to procedure.A manufacturing batch record review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a device history record (dhr) review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 standard capacity biopsy forceps was used in a procedure performed on an unknown date.During the procedure, the biopsy forceps got stuck in the insertion port of the endoscope.Fluoroscopy noted deformation around the base of the cups.The scope could no longer be used; therefore, the procedure was aborted.The endoscope was sent to the manufacturer for investigation, together with the biopsy forceps that could not be removed.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Additional information received as of december 10, 2021: the procedure was performed on early august.According to the olympus report and photo, the clevis arms is bent.

• 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: 12955252
• Report Number: 3005099803-2021-06249
• Device Sequence Number: 4317196
• Product Code: FCL
• UDI-Device Identifier: 08714729777960
• UDI-Public: 08714729777960
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2022

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 Model Number: M00513401
• Device Catalogue Number: 1340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 12/10/2021; 03/08/2022
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 01/06/2022; 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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