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

Model Number	2192
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the balloon was stuck inside the patient's body.There was no reported patient involvement and outcome.
Additional Manufacturer Narrative
Device evaluation technical support confirmed the calibration error.A visual inspection showed no issues there was no external damage to the probe.The unit was tested and showed calibration errors on channel 6 and b1.There were no visible signs of mishandling/damage.The investigation found the most probable cause to be the sensor failure.But a root cause was not identified.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the balloon was stuck inside the patient's body.The device has been returned for investigation.The unit has been tested and showed calibration errors on channel 6 and 31 with no visible signs of mishandling or damage.There was no reported patient involvement and outcome.

• Brand Name: MANOSCAN
• Common Device Name: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): GIVEN IMAGING LOS ANGELES LLC; 5860 uplander way; culver city CA 90230
• MDR Report Key: 7498761
• Report Number: 3005344223-2018-00004
• Device Sequence Number: 109418
• Product Code: FFX
• UDI-Device Identifier: 04260167482477
• UDI-Public: 04260167482477
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K091070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2018

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 Model Number: 2192
• Device Catalogue Number: 2192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 05/09/2018
• Supplement Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1