MAUDE Adverse Event Report: ACORN VAGINAL MANIPULATOR

Device Problems Component Falling (1105); Loose or Intermittent Connection (1371)

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

Event Date 11/25/2013

Event Type  malfunction  

Event Description

Screw from acorn manipulator became loose during vaginal hysterectomy.Screw fell from patient's vagina when she stood up.

• Brand Name: VAGINAL MANIPULATOR
• Type of Device: VAGINAL MANIPULATOR
• Manufacturer (Section D): ACORN; carmel 46032
• MDR Report Key: 3815358
• MDR Text Key: 16057742
• Report Number: MW5036107
• Device Sequence Number: 1
• Product Code: LKF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 55