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

Model Number	M00513441
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 pediatric biopsy forceps was used during a biopsy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, when opening the cups inside the patient, an object that looks like a loose thread was found attached.The procedure was completed with this device.No foreign object was detached inside the patient.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Device code 2944 captures the reportable event of foreign matter inside the cup.Visual examination found the returned device does not have any visible failure.It was inspected and all the components are present and are in correct position.No foreign matter was present.After analysis it was determined that the device did not present any visual issue.Returned device review includes a visual evaluation, which showed no evidence of either the alleged issue or any defect that could have contributed to the event reported.Therefore, the investigation conclusion code for this complaint 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 pediatric biopsy forceps was used during a biopsy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, when opening the cups inside the patient, an object that looks like a loose thread was found attached.The procedure was completed with this device.No foreign object was detached inside the patient.There were no patient complications reported as a result of this event.

• 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: 8248810
• Report Number: 3005099803-2019-00046
• Device Sequence Number: 2280224
• Product Code: FCL
• UDI-Device Identifier: 08714729789918
• UDI-Public: 08714729789918
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2019

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: 07/16/2021
• Device Model Number: M00513441
• Device Catalogue Number: 1344
• Device Lot Number: 0022384760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2019
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1