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

Model Number 3890

Device Problem Difficult to Remove (1528)

Patient Problems Discomfort (2330); Injury (2348)

Event Date 10/16/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, after completing the study, the catheter was stuck and was unable to be withdrawn from the nostril.It was stuck at the joint between the sensor part and the pvc sheath.It required ent and endoscopy intervention to remove the device.The patient had increased discomfort due to the prolonged intubation of the catheter.The patient experienced some trauma to the nostril when the catheter was removed by the ent and endoscopy.The device worked correctly during the previous procedure.

• Brand Name: MANOSCAN
• Type of Device: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): GIVEN IMAGING LOS ANGELES LLC; 5860 uplander way; culver city CA 90230
• Manufacturer (Section G): GIVEN IMAGING LOS ANGELES LLC; 5860 uplander way; culver city CA 90230
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 10789963
• MDR Text Key: 214752579
• Report Number: 3005344223-2020-00008
• Device Sequence Number: 1
• Product Code: FFX
• UDI-Device Identifier: 04260167482446
• UDI-Public: 04260167482446
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K151086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3890
• Device Catalogue Number: 3890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR