MAUDE Adverse Event Report: GIVEN IMAGING LOS ANGELES MANOSHIELD 3DAR; SYSTEM, GASTROINTESTINAL MOTILITY

Model Number MSS-4581-3D

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Reference#: (b)(4).The sample has been requested but to date the incident sample has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

Customer reported difficult removal of the 3dar manoshield.When it was finally removed the balloon broke off remaining inside of the patient.They attempted to digitally remove the balloon but were not successful.Physician advised to let the patient pass the balloon with their next bowel movement.There was no injury to the patient.Physician believes this was due to anatomical structure as the study showed very high pressures during event frames and in between.

• Brand Name: MANOSHIELD 3DAR
• Type of Device: SYSTEM, GASTROINTESTINAL MOTILITY
• Manufacturer (Section D): GIVEN IMAGING LOS ANGELES; 5860 uplander way; culver city CA 90230
• Manufacturer (Section G): GIVEN IMAGING LOS ANGELES; 5860 uplander way; culver city CA 90230
• Manufacturer Contact: sharon murphy ; 540 oakmead parkway; sunnyvale, CA 94085 ; 2034925267
• MDR Report Key: 5780454
• MDR Text Key: 49126666
• Report Number: 9710107-2016-00298
• Device Sequence Number: 1
• Product Code: FFX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Model Number: MSS-4581-3D
• Device Catalogue Number: MSS-4581-3D
• Device Lot Number: F1537303UA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1