MAUDE Adverse Event Report: GIVEN GILA (LOS. ANGELES) MANOSCAN ESO CATHETER, RFG; SYSTEM, GASTROINTESTIONAL MOTILITY (ELECTRICAL)

Model Number RFG-1286

Device Problem Device Damaged Prior to Use (2284)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, the tpe was damaged during a difficult extubation.The customer said that the catheter calibrates but she can see a small hole in the tpe where it is curled.No other known adverse events were reported.

• Brand Name: MANOSCAN ESO CATHETER, RFG
• Type of Device: SYSTEM, GASTROINTESTIONAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): GIVEN GILA (LOS. ANGELES); 5860 uplander way; culver city CA 90230
• Manufacturer (Section G): GIVEN GILA (LOS. ANGELES); 5860 uplander way; culver city CA 90230
• Manufacturer Contact: sharon murphy ; 540 oakmead parkway; sunnyvale, CA 95126 ; 2034925267
• MDR Report Key: 6021940
• MDR Text Key: 57187532
• Report Number: 3005344223-2016-00002
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RFG-1286
• Device Catalogue Number: RFG-1286
• Device Lot Number: EAN2547
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2016
• 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