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

Model Number FGS-0313

Device Problem Loss of or Failure to Bond (1068)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 06/10/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the capsule failed to attach.There was no reported patient outcome.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, they had a capsule which failed to attach.There was no harm to the patient but a repeat procedure was performed.An endoscope was used to sweep the metal chip through the upper esophagus into stomach.There was nothing unusual about the patient or the procedure and an endoscopy had been performed prior to the procedure and showed the esophagus to be normal.Lubrication was used to facilitate the placement of the capsule.

Manufacturer Narrative

Evaluation summary: this report is based on information provided by the complaint tracking system.According to cs text in (b)(4) a product sample of the capsule was provided by mitg analysis but was not provided to (b)(4) investigation team.Per tech support description there is no enough information to determine if product whether or not product meet spec.Since no sample arrived at (b)(4) for investigation, visual inspection cannot be performed.The customer reported they had a capsule which failed to attach.Per tech support description there is no enough information to determine if product whether failure has been confirmed or not.The investigation performed by tech support did not determine the issue cause.The investigation performed by tech support did not determine the cause of the reported issue.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, they had a capsule which failed to attach.There was no harm to the patient but a repeat procedure was performed.An endoscope was used to sweep the metal chip through the upper esophagus into stomach.There was nothing unusual about the patient or the procedure and an endoscopy had been performed prior to the procedure and showed the esophagus to be normal.Lubrication was used to facilitate the placement of the capsule and the delivery system and capsule will be returned for investigation.

Manufacturer Narrative

Evaluation summary: one device was received for evaluation.The investigation found the device to function normally and within specifications.A review of the device history records indicated that this serial/lot number was released meeting all specifications as manufactured.If information is provided in the future, a supplemental report will be issued.

• 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 ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 8785046
• MDR Text Key: 150842674
• Report Number: 9710107-2019-00332
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101361688
• UDI-Public: 07290101361688
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/15/2020

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 Expiration Date: 03/14/2020
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 44902Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2019
• Initial Date FDA Received: 07/12/2019
• Supplement Dates Manufacturer Received: 09/25/2019; 11/20/2019; 04/02/2020
• Supplement Dates FDA Received: 10/14/2019; 12/05/2019; 04/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2019
• 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
• Patient Age: 70 YR
• Patient Weight: 78