MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPIO; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	M0068312321
Medical Device Problem Codes	Misfire (2532); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a capio pc device was used during a procedure performed on (b)(6) 2019.According to the compainant, during the procedure, the device misfired and did not load properly.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: CAPIO
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9119792
• Report Number: 3005099803-2019-04632
• Device Sequence Number: 2614755
• Product Code: GCJ
• UDI-Device Identifier: 08714729257622
• UDI-Public: 08714729257622
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K932553
• 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): 09/25/2019

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: 01/06/2022
• Device Model Number: M0068312321
• Device Catalogue Number: 831-232
• Device Lot Number: 0023148867
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/25/2019
• Patient Sequence Number: 1