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

Model Number FGS-0636

Device Problem Failure to Calibrate (2440)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, when the first capsule was being calibrated, the patient was placed under anesthesia.However, the first capsule failed to calibrate, and a second capsule was used, but it still failed.The physician completed esophagogastroduodenoscopy without placing the capsule and a repeat procedure was necessary.Technical support informed the customer that the capsule was calibration free.They did not have a compatible recorder for calibration free capsules.There was no patient injury.

Manufacturer Narrative

Evaluation summary: this report is based on information provided by medtronic investigation personnel and (b)(4) device arriving in bio lab.(b)(4) device (capsule and delivery) was received for evaluation.Since inadequate sample was returned for investigation it is impossible to determine if product meet specs or not.The visual inspection found no issues.The customer reported the first capsule failed to calibrate, and a second capsule was used, but it still failed.An investigation of the returned equipment was not performed since the sample was sent as bio-hazard contaminated to the lab and is not a bio-hazard device.Evaluation was not performed since the product sample did not arrive for investigation in a proper manner allowing investigation.The investigation could not determine a cause or a probable root cause for the customer's report based on the information provided and sample received.The bio-hazard procedure states: it is forbidden to open contaminated returned equipment outside bio lab.All parts transferred to the biohazard lab will be considered as contaminated.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BRAVO CAPSULE
• 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: 8569515
• MDR Text Key: 143707024
• Report Number: 9710107-2019-00193
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101369714
• UDI-Public: 07290101369714
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2020
• Device Model Number: FGS-0636
• Device Catalogue Number: FGS-0636
• Device Lot Number: 44103F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2019
• 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: 78 YR
• Patient Weight: 116