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

Model Number	M00515181
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 pulmonary biopsy forceps was used in the lungs during a biopsy procedure performed in (b)(6) 2019.According to the complainant, during the procedure, the jaws remains in semi open position and would not stay close.The procedure was completed with this device.No patient complications were reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: problem code 2921 captures the reportable event of jaws failure to close.Block h10: visual inspection found the returned device in good condition and no visual damage was noted.Dimensional and functional inspection was performed and no anomalies were noted.The analysis of the returned device found no evidence of either the alleged issue or any defect that could have contributed to the reported event.Therefore, the most probable cause is "no problem detected".A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 pulmonary biopsy forceps was used in the lungs during a biopsy procedure performed in (b)(6), 2019.According to the complainant, during the procedure, the jaws remains in semi open position and would not stay close.The procedure was completed with this device.No patient complications were reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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
• MDR Report Key: 9482062
• Report Number: 3005099803-2019-06122
• Device Sequence Number: 19565596
• Product Code: FCL
• UDI-Device Identifier: 08714729792864
• UDI-Public: 08714729792864
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2020

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: 11/01/2021
• Device Model Number: M00515181
• Device Catalogue Number: 1518
• Device Lot Number: 0022883393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 02/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1