MAUDE Adverse Event Report: GIVEN IMAGING, INC. C F CAPSULE; ELECTRODE PH, STOMACH

Lot Number 45805F

Device Problem Separation Failure (2547)

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

Event Date 06/20/2019

Event Type  malfunction  

Event Description

Resistance during deployment of capsule from delivery device.Device was still attached to capsule and would not separate from the mucosa.The handle was broken as designed to release the wire from the capsule, but the capsule was still attached.

• Brand Name: C F CAPSULE
• Type of Device: ELECTRODE PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING, INC. ; mansfield MA 02048
• MDR Report Key: 8785472
• MDR Text Key: 151028030
• Report Number: MW5088052
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• 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: 06/21/2019

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: 07/11/2020
• Device Lot Number: 45805F
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/11/2019
• 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: 33 YR
• Patient Weight: 68