MAUDE Adverse Event Report: THE O R COMPANY PTY LTD OBELIS VAGINAL MANIPULATOR SIZE 35-M; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Model Number REF UE-OBPRO-35

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 06/21/2023

Event Type  malfunction  

Event Description

Vaginal manipulator balloon torn when attempted to be retrieved from patient's wound cavity.

• Brand Name: OBELIS VAGINAL MANIPULATOR SIZE 35-M
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): THE O R COMPANY PTY LTD
• MDR Report Key: 17202447
• MDR Text Key: 318032438
• Report Number: MW5118822
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REF UE-OBPRO-35
• Device Catalogue Number: REF UE-OBPRO-35
• Device Lot Number: 2302036
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 53 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White