MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) CAPIO¿; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number M0068311251

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a capio¿ device was used during an anterior and posterior vaginal repair procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the dart broke off and got stuck in carrier in the lower part of the device.Reportedly, upon closer inspection, the capio device was not properly lining up.The procedure was completed with another capio¿ device.The patient's condition at the conclusion of the procedure was reported to be of no harm.

Event Description

It was reported to boston scientific corporation that a capio device was used during an anterior and posterior vaginal repair procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the dart broke off and got stuck in carrier in the lower part of the device.Reportedly, upon closer inspection, the capio device was not properly lining up.The procedure was completed with another capio device.The patient's condition at the conclusion of the procedure was reported to be of no harm.

Manufacturer Narrative

Analysis of the returned capio opc device revealed that it does not have any visual failure.Also, the carrier was actuated three times and it extended and retracted without any issues.Also, it was actuated (deployed) three times with the suture and the needle entered in the slot without any issues, consequently not confirming the reported complaint.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.The investigation concluded that the device did not present any visual issue and it worked as intended.Returned device review includes visual and functional evaluations, which showed no evidence of either the alleged issue or any defect that could have contributed to the event reported.

• Brand Name: CAPIO¿
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7405299
• MDR Text Key: 104848025
• Report Number: 3005099803-2018-00867
• Device Sequence Number: 1
• Product Code: FHQ
• UDI-Device Identifier: 08714729257615
• UDI-Public: 08714729257615
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/12/2018

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
• Device Operator: Physician
• Device Expiration Date: 11/12/2020
• Device Model Number: M0068311251
• Device Catalogue Number: 831-125
• Device Lot Number: 21362107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Initial Date Manufacturer Received: 03/12/2018
• Initial Date FDA Received: 04/06/2018
• Supplement Dates Manufacturer Received: 10/03/2018
• Supplement Dates FDA Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1