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

Model Number	M0068312321
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis.Upon 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 packaged, pc device was used during a total hysterectomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the dart detached on the patient's left side and was noticed after the capio device was deployed.Reportedly, a portable x-ray was used to confirm that the detached piece was not inside the patient.The procedure was completed with another capio packaged, pc device.There were no patient complications as a result of the event.The patient's condition at the conclusion of the procedure was reported to be good.
Additional Manufacturer Narrative
Blocks b5 and b7 fields were updated due to additional information received.Block h6: device code of 2907 captures the reportable event of dart detachment.Block h10: the voluntary user medwatch number is (b)(4).Investigation of the returned capio slim device was performed.Visual analysis found that there were blood residues observed on the device.There were no issues observed with the catch and carrier.The 4 riveting pins were in place.The cage did not have rough edges.Furthermore, the dart was not returned in the device.Functional analysis was performed by actuating the carrier three times and it extended and retracted without any issues.Also, it was actuated (deployed) three times with the suture and the dart could be entered in the catch slot without any issues.A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.After analysis it was determined that the device did not present any visual issue and it worked as intended.It did not show evidence of either the alleged issue or any defect that could have contributed to the event reported.Therefore, the investigation concluded that the most probable cause for the reported issue is no problem detected, since the device complaint or problem cannot be confirmed.
Event or Problem Description
It was reported to boston scientific corporation that a capio packaged, pc device was used during a total hysterectomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the dart detached on the patient's left side and was noticed after the capio device was deployed.Reportedly, the detached dart was stuck inside the capio device.Furthermore, a portable x-ray was used to confirm that the detached piece was not inside the patient.The procedure was completed with another capio packaged, pc device.There were no patient complications as a result of the event.The patient's condition at the conclusion of the procedure was reported to be good.

• 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: 9809258
• Report Number: 3005099803-2020-00711
• Device Sequence Number: 19583884
• Product Code: GCJ
• UDI-Device Identifier: 08714729257622
• UDI-Public: 08714729257622
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K932553
• 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): 04/07/2020

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: 03/14/2022
• Device Model Number: M0068312321
• Device Catalogue Number: 831-232
• Device Lot Number: 0023495814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 04/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 73