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

Model Number	M00513411
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	05/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual analysis found one of the jaws/cups was bent and misaligned and the clevis was found bent.There were no missing components.There were two metallic pieces found inside the opened packaging received along with the returned device.The evaluation concluded that the metallic pieces were determined to be foreign matter as they were not part of the biopsy forceps.The analysis failed to indicate a probable root cause, therefore the root cause for this complaint is undeterminable.The device history record review found the device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 standard capacity biopsy forceps was to be used in a biopsy procedure in the oesophagus performed on (b)(6) 2017.According to the complainant, during preparation, it was noted that a bit of metal had come off at the end of the jaws while inside the device packaging.The procedure was completed with another of the same device.There were no patient complications reported a result of this event.This event has been deemed a reportable event based on the investigation results; foreign matter.

• 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: 6703918
• Report Number: 3005099803-2017-02045
• Device Sequence Number: 762501
• Product Code: FCL
• UDI-Device Identifier: 08714729777984
• UDI-Public: (01)08714729777984(17)20190813(10)0019592939
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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
• Report Date (Section B): 06/15/2017

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: 08/13/2019
• Device Model Number: M00513411
• Device Catalogue Number: 1341
• Device Lot Number: 0019592939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2017
• Initial Report FDA Received Date: 07/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1