MAUDE Adverse Event Report: BUFFALO FILTER, LLC LAPAROVUE; ANTI FOG SOLUTION AND ACCESSORIES, ENDOSCOPY

Model Number 132393

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 02/09/2018

Event Type  malfunction  

Event Description

The lapvue swab device was being used to clean the davinci xi robotic trocar and the swab part of the device broke off before being successfully removed.The swab landed on the abdominal cavity of the patient.It was located by the surgeon, and was removed prior to surgical completion.No harm was done to the patient.

• Brand Name: LAPAROVUE
• Type of Device: ANTI FOG SOLUTION AND ACCESSORIES, ENDOSCOPY
• Manufacturer (Section D): BUFFALO FILTER, LLC; 5900 genesee street; lancaster NY 14086
• MDR Report Key: 7457606
• MDR Text Key: 106449260
• Report Number: 7457606
• Device Sequence Number: 1
• Product Code: OCT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 132393
• Device Lot Number: 135125
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/23/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: THIS EVENT OCCURRED DURING ROBOTIC SURGERY.
• Patient Age: 78 YR
• Patient Weight: 91