MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM BRAVO; ELECTRODE, PH, STOMACH

Model Number FGS-0313

Device Problem Misconnection (1399)

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

Event Date 01/08/2018

Event Type  malfunction  

Event Description

According to the reporter, the unit calibrated and was placed in the patient then it got stuck on waiting for ph capsule 1.The recorder was turned off and back on but still would not detect the capsule.They did not have another recorder to check if it would detect the capsule so they decided to calibrate and place a second capsule which was successful.This occurred one hour after the initial placement, and additional anesthesia was used.Per tech support, the customer will send in a picture of the device for possible replacement and the replacement was confirmed.No reported patient outcome.

Manufacturer Narrative

Correction:the sample was not returned to medtronic for evaluation but a photo of the device was sent.The photo was not enough to perform an evaluation.Without the sample a detailed investigation could not be performed.The file will be closed as unconfirmed at this time.If additional information is obtained, or the sample is returned, we will reopen this investigation.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the unit calibrated and was placed in the patient then it got stuck on waiting for ph capsule 1.The recorder was turned off and back on but still would not detect the capsule.They did not have another recorder to check if it would detect the capsule so they decided to calibrate and place a second capsule which was successful.This occurred one hour after the initial placement, and additional anesthesia was used.Per tech support, the customer will send in a picture of the device for possible replacement and the replacement was confirmed.No reported patient outcome.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer Contact: amy beeman ; 15 hampshire st.; mansfield, MA 02048 ; 7632104064
• MDR Report Key: 7229130
• MDR Text Key: 98637101
• Report Number: 9710107-2018-00178
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2018

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
• Device Operator: Health Professional
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 36090Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/12/2018
• Initial Date FDA Received: 01/30/2018
• Supplement Dates Manufacturer Received: 04/26/2018
• Supplement Dates FDA Received: 06/29/2018
• 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