MAUDE Adverse Event Report: GIVEN IMAGING LTD. BRAVO PH CAPSULE DELIVERY SYSTEM; ELECTRODE PH STOMACH

Catalog Number FGS-0313

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)

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

Event Date 09/05/2019

Event Type  malfunction  

Event Description

During an egd, physician attempted to deploy capsule on a medtronic bravo ph unit when part of the plunger broke off - unit disassembled; per mfg guide lines and capsule manually deployed without further issue.

• Brand Name: BRAVO PH CAPSULE DELIVERY SYSTEM
• Type of Device: ELECTRODE PH STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD.
• MDR Report Key: 9245147
• MDR Text Key: 164288299
• Report Number: MW5090711
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2019
• Device Catalogue Number: FGS-0313
• Device Lot Number: 42740
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 54