MAUDE Adverse Event Report: STERIS UNITED STATES ENDOSCOPY GROUP, INC. STERIS ADVANCE DELIVERY DEVICE VIDEO CAPSULE DEPLOYMENT DEVICE; SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE

Model Number BX00711144

Device Problem Entrapment of Device (1212)

Patient Problem Insufficient Information (4580)

Event Date 12/02/2021

Event Type  Injury  

Event Description

Video capsule did not deploy from capsule container.When endoscope was removed it was noted that the deployment cable was found lodged between the video capsule and the delivery system.Fda safety report id # (b)(4).

• Brand Name: STERIS ADVANCE DELIVERY DEVICE VIDEO CAPSULE DEPLOYMENT DEVICE
• Type of Device: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
• Manufacturer (Section D): STERIS UNITED STATES ENDOSCOPY GROUP, INC.
• MDR Report Key: 13011264
• MDR Text Key: 282358678
• Report Number: MW5106052
• Device Sequence Number: 1
• Product Code: NEZ
• 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: 12/10/2021

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 Model Number: BX00711144
• Device Lot Number: 2107998
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White