MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) RADIAL JAW¿ 4; FORCEPS, BIOPSY, NON-ELECTRIC

Model Number	M00513321
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	03/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a hair was noted inside the unopened package of a radial jaw¿ 4 biopsy forceps.The procedure was completed with another radial jaw¿ 4 biopsy forceps device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a hair was noted inside the unopened package of a radial jaw¿ 4 biopsy forceps.The procedure was completed with another radial jaw¿ 4 biopsy forceps device.There were no patient complications 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
Visual analysis of the returned unused device found the pouch sealed and the sterile barrier is intact.Visual assessment identified a hair inside the pouch.The investigation concluded that the most probable cause for this event is "manufacturing execution error" as the design or validation of the manufacturing process was not executed since a hair was found inside the pouch.There is an investigation in place to address this issue.The device history record review found the device met all manufacturing specifications.A search of the complaint database confirmed that no similar complaints exist for the specified batch.

• Brand Name: RADIAL JAW¿ 4
• Common Device Name: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 6916001
• Report Number: 3005099803-2017-03054
• Device Sequence Number: 19093039
• Product Code: FCL
• UDI-Device Identifier: 08714729648796
• UDI-Public: 08714729648796
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 09/11/2017

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: 08/10/2019
• Device Model Number: M00513321
• Device Catalogue Number: 1332-20
• Device Lot Number: 0019580462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Initial Date Received by Manufacturer: 09/11/2017
• Supplement Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1