MAUDE Adverse Event Report: GIVEN IMAGING LTD MANOSCAN ESO Z CATHETER; SYSTEM, GASTROINTESTIONAL MOTILITY (ELECTRICAL)

Model Number 3890

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/31/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According the reporter, the catheter was stuck in a patient and couldn't be removed.The facility's ent department were able to safely remove it.They suspect an undiagnosed deviated nasal septim as the reason for the difficulty in removing the catheter.

• Brand Name: MANOSCAN ESO Z CATHETER
• Type of Device: SYSTEM, GASTROINTESTIONAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): GIVEN IMAGING LTD; 2 hacarmel street; p.o box 258; new industrial park, yoqneam 20692 ; IS 20692
• Manufacturer (Section G): GIVEN IMAGING LTD; 2 hacarmel street; p.o. box 258; new industrial park, yoqneam 20692 ; IS 20692
• Manufacturer Contact: sharon murphy ; 540 oakmead parkway; sunnyvale, CA 94085 ; 2034925267
• MDR Report Key: 5609564
• MDR Text Key: 44379379
• Report Number: 9710107-2016-00153
• 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: Other
• Type of Report: Initial
• Report Date: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 3890
• Device Catalogue Number: 3890
• Device Lot Number: EAZ3748
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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