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

Model Number	RFG-3890
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Blood Loss (2597)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, when they attempted to extubate the patient, but the probe was stuck, and they had a difficulty removing it.They had to contact the ears, nose, throat (ent) department which took 2 hours.The catheter was in the patient's cricothyroid and they had to use a scope to check the location and remove it.The patient experience bleeding in the nasal cavity, but they were able to stop the bleeding and the patient was stable.They will not repeat the study.Technical support connected to the system and completed a search for the file but was still unable to find the study.

• 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: 8100693
• Report Number: 3005344223-2018-00012
• Device Sequence Number: 1332738
• Product Code: FFX
• UDI-Device Identifier: 04260167482507
• UDI-Public: 4260167482507
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K151086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2018

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 Model Number: RFG-3890
• Device Catalogue Number: RFG-3890
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 11/26/2018
• 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: Required Intervention