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

Model Number	M0068312321
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(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 device was used during a vaginal hysterectomy with anterior repair performed on (b)(6) 2018.According to the complainant, during the procedure, upon retracting the capio, the carrier tip detached.The physician then performed an x-ray but he did not found the carrier tip.It was reported that the tip was left inside the patient and he was not able to retrieve it, subsequently.The procedure was completed with the capio device.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 stable.
Event or Problem Description
It was reported to boston scientific corporation that a capio device was used during a vaginal hysterectomy with anterior repair performed on (b)(6) 2018.According to the complainant, during the procedure, upon retracting the capio, the carrier tip detached.The physician then performed an x-ray but he did not found the carrier tip.It was reported that the tip was left inside the patient and he was not able to retrieve it, subsequently.The procedure was completed with the capio device.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 stable.

• Brand Name: CAPIO¿
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7391316
• Report Number: 3005099803-2018-00953
• Device Sequence Number: 19145495
• Product Code: GCJ
• UDI-Device Identifier: 08714729257622
• UDI-Public: 08714729257622
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/18/2019
• Device Model Number: M0068312321
• Device Catalogue Number: 831-232
• Device Lot Number: 19983956
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2018
• Supplement Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 04/03/2018
• Supplement Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Weight: 75