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

Model Number	M00513412
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	05/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 standard capacity biopsy forceps was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, when the forceps was passed through the scope and the jaws was opened, a foreign body was found inside the cup.The forceps was immediately withdrawn from the patient.The procedure was completed with another radial jaw biopsy forceps.There were no patient complications reported as a result of this event.The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¿.
Additional Manufacturer Narrative
Visual examination found the returned device does not present any visual issue nor foreign matter.However, additional information provided pictures were a foreign matter is noted.The issue occurred during the procedure and inside the patient.This could contribute to the acquisition of the foreign matter.Visual examination showed no evidence of either the alleged issue or any defect that could have contributed to the event reported.Therefore the most probable cause for the complaint is "not confirmed-returned".A review of the device history record (dhr) was performed and no deviation was found.A search of the complaint database confirmed that no similar complaints exist for the specified batch. .
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw¿ 4 standard capacity biopsy forceps was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, when the forceps was passed through the scope and the jaws was opened, a foreign body was found inside the cup.The forceps was immediately withdrawn from the patient.The procedure was completed with another radial jaw biopsy 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: 7567006
• Report Number: 3005099803-2018-01799
• Device Sequence Number: 2629640
• Product Code: FCL
• UDI-Device Identifier: 08714729778004
• UDI-Public: 08714729778004
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2018

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: 03/11/2021
• Device Model Number: M00513412
• Device Lot Number: 0021852753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 06/04/2018
• Supplement Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1