MAUDE Adverse Event Report: COOPERSURGICAL, INC. ALLY UTERINE POSITIONING SYSTEM UTERINE DELINEATOR ; CANNULA, MANIPULATOR / INJECTOR, UTERINE

Model Number ALLY UPS

Device Problems Material Perforation (2205); Physical Resistance/Sticking (4012)

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

Event Date 02/26/2020

Event Type  Injury  

Event Description

Uterine delineator machine was unlocked to move the arm, the mechanism stuck and when release the uterine delineator moved unexpectedly and the unit perforated the bladder.Fda safety report id # (b)(4).

• Brand Name: ALLY UTERINE POSITIONING SYSTEM UTERINE DELINEATOR
• Type of Device: CANNULA, MANIPULATOR / INJECTOR, UTERINE
• Manufacturer (Section D): COOPERSURGICAL, INC.
• MDR Report Key: 9780160
• MDR Text Key: 182215046
• Report Number: MW5093491
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ALLY UPS
• 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 Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 62