MAUDE Adverse Event Report: GIVEN IMAGING VIETNAM CO LTD ManoScan; SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Model Number	3890
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Remove (1528); Loss of Data (2903)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction

• Brand Name: ManoScan
• Common Device Name: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): GIVEN IMAGING VIETNAM CO LTD; suite 6a, 6th floor; ho chi minh city ; VM
• Manufacturer (Section G): GIVEN IMAGING VIETNAM CO LTD; suite 6a, 6th floor; ho chi minh city ; VM
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(800)646-4633
• MDR Report Key: 50829201
• Report Number: 3007662958-2026-00003
• Device Sequence Number: 13409203
• Product Code: FFX
• UDI-Device Identifier: 04260167482446
• UDI-Public: (01)04260167482446(11)260306(20)01
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K091070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 3890
• Device Catalogue Number: 3890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 03/06/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown