MAUDE Adverse Event Report: COOPERSURGICAL, INC. ADVINCULA DELINEATOR UTERINE MANIPULATOR WITH 3.0CM STAINLESS STEEL KOH-EFFICIEN; CULDOSCOPE (AND ACCESSORIES)

Catalog Number AD750-KES30

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2023

Event Type  malfunction  

Event Description

After positioning the disposable uterine manipulator in the correct position, the surgeon went to inflate the balloon and it would not inflate.Another manipulator was obtained, and the case proceeded.No harm to the patient during the device failure.Advincula delineator uterine manipulator with 3.0cm stainless steel koh-efficient.Cooper surgical.Ref: ad750-kes30 / lot: 331568 / exp: 03/28/2026.

• Brand Name: ADVINCULA DELINEATOR UTERINE MANIPULATOR WITH 3.0CM STAINLESS STEEL KOH-EFFICIEN
• Type of Device: CULDOSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): COOPERSURGICAL, INC.
• MDR Report Key: 18326068
• MDR Text Key: 330602129
• Report Number: MW5149236
• Device Sequence Number: 1
• Product Code: HEW
• 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: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AD750-KES30
• Device Lot Number: 331568
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White