MAUDE Adverse Event Report: GIVEN IMAGING LOS ANGELES MANOSCAN; SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Model Number	MSS-3598
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During anorectal manometry procedure patient was not cooperating.When physician removed manometer from patient, catheter came out but balloon and dental floss were retained in patient rectum.Unable to be manually removed.Patient did not pass balloon while at hospital or follow directions to monitor stool for passage of balloon post-op.The balloon is about 2 inches long and tied to manometer with 2 pieces of dental floss.

• Brand Name: MANOSCAN
• Common Device Name: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): GIVEN IMAGING LOS ANGELES; 5860 uplander way; culver city CA 90230
• MDR Report Key: 8703389
• Report Number: 8703389
• Device Sequence Number: 11315502
• Product Code: FFX
• UDI-Device Identifier: 07290101365600
• UDI-Public: (01)07290101365600
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2019
• Report Date (Section F): 06/13/2019

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 Model Number: MSS-3598
• Device Catalogue Number: MSS-3598
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/17/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2019
• Patient Sequence Number: 1
• Patient Weight: 93
• Date Report Sent to FDA: 06/13/2019