MAUDE Adverse Event Report: AMS ARTIFICIAL BOWEL SPHINCTER; NONE

Model Number 10 CM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 01/24/2014

Event Type  malfunction  

Event Description

Malfunction of the cuff portion of the artificial bowel sphincter.The cuff was open on the x-ray which was consistent with physical findings.Pt underwent revision of the cuff portion of the artificial bowel sphincter on (b)(6) 2014.As seen preoperatively, the cuff had opened.Repeat sizing was carried out, number 10 size was correct and the cuff was replaced.

• Brand Name: ARTIFICIAL BOWEL SPHINCTER
• Type of Device: NONE
• Manufacturer (Section D): AMS; minnestonka 55343
• MDR Report Key: 3906273
• MDR Text Key: 4647839
• Report Number: MW5036936
• Device Sequence Number: 1
• Product Code: MIP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/25/2014

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: 01/04/2016
• Device Model Number: 10 CM
• Device Catalogue Number: 72401978
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/26/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 104