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

Model Number	M00546270
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/15/2017
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
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report# 3005099803-2017-03052 for the first spybite biopsy forceps, and 3005099803-2017-03053 for the second spybite biopsy forceps.It was reported to boston scientific corporation that a spybite biopsy forceps was unpacked on (b)(6) 2017.According to the complainant, during unpacking, it was noticed that there "seemed to be bile and dirt was noticed." there was no procedure involved and the device was not used in the patient.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
The spybite biopsy forceps was received inside of the original unopened box.The label of the outer box has a blue stain.All the information of the label is complete and legible.The outer box was never opened and the reported foreign matter was noted on the outside box; not on the spybite biopsy forceps.The investigation concluded that the blue stain found did not present any visual issue and the label was within specification.The returned device did not show evidence of either the alleged malfunction or any defect that could have contributed to the event.Therefore, the most probable cause for this complaint is handling damage.A dhr (device history record) review was performed and no deviation was found.A search of the complaint database confirmed that no other complaints exist for the specified batch.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report# 3005099803-2017-03052 for the first spybite biopsy forceps, and 3005099803-2017-03053 for the second spybite biopsy forceps.It was reported to boston scientific corporation that a spybite biopsy forceps was unpacked on (b)(6) 2017.According to the complainant, during unpacking, it was noticed that there "seemed to be bile and dirt was noticed." there was no procedure involved and the device was not used in the patient.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: SPYBITE¿
• 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: 6945330
• Report Number: 3005099803-2017-03052
• Device Sequence Number: 19219753
• Product Code: FCL
• UDI-Device Identifier: 08714729764458
• UDI-Public: 08714729764458
• Combination Product (Y/N): N
• 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): 09/15/2017

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: 05/01/2020
• Device Model Number: M00546270
• Device Catalogue Number: 4627
• Device Lot Number: 20592934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 11/05/2017
• Initial Report FDA Received Date: 10/12/2017
• Supplement Report FDA Received Date: 12/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1