MAUDE Adverse Event Report: BOSTON SCIENTIFIC CAPIO STANDARD SUTURE CAPTURING DEVICE; HOLDER, NEEDLE, GASTROENTEROLOGIC

Catalog Number	M0068312320
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Capio instrument failure: tip retained during anterior repair.

• Brand Name: CAPIO STANDARD SUTURE CAPTURING DEVICE
• Common Device Name: HOLDER, NEEDLE, GASTROENTEROLOGIC
• Manufacturer (Section D): BOSTON SCIENTIFIC; el coyol, alajuela, cr
• MDR Report Key: 7475180
• Report Number: MW5076908
• Device Sequence Number: 1416834
• Product Code: FHQ
• UDI-Device Identifier: 08714729753087
• UDI-Public: (01)08714729753087(17)191118(10)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/26/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/16/2020
• Device Catalogue Number: M0068312320
• Device Lot Number: 19983956
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2018
• 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