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

Model Number	M00513331
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	04/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
This report pertains to one of two devices used during the same procedure.Refer to manufacturer report #3005099803-2018-01418 for the first radial jaw¿ 4 biopsy forceps and manufacturer report#3005099803-2018-01419 for the second radial jaw¿ 4 biopsy forceps.It was reported to boston scientific corporation that radial jaw¿ 4 biopsy forceps was used in the stomach during a esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2018.According to the complainant, during preparation, a sticky glue was found on the forceps.The forceps was not used in the patient and was discarded.Another package was opened and found glue on the forceps as well.The procedure was completed with the third radial jaw forceps.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 ¿fine¿.

• 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: 7467319
• Report Number: 3005099803-2018-01419
• Device Sequence Number: 1476447
• Product Code: FCL
• UDI-Device Identifier: 08714729648819
• UDI-Public: 08714729648819
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/12/2018

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: 02/06/2021
• Device Model Number: M00513331
• Device Catalogue Number: 1333-20
• Device Lot Number: 21716128
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1