MAUDE Adverse Event Report: COOPERSURGICAL, INC. RUMI II KOH-EFFICIENT; CULDOSCOPE (AND ACCESSORIES)

Device Problem Product Quality Problem (1506)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2005

Event Type  Injury  

Event Description

Dear fda, the rumi uterus manipulator k954311 has a huge design mistake that could lead to misuse and rupture of the uterus.It was mentioned in a paper published in 2005.And i was surprised that in the product approval form that is submitted to you https://www.Accessdata.Fda.Gov/cdrh_docs/pdf/k954311.Pdf last page last paragraph "performance test" that the balloon can hold 250 cc, why? the uterus can hold 20-25 cc and will rupture.Two cases happened and documented in the literature https://pubmed.Ncbi.Nlm.Nih.Gov/15904626/ i call this device the uteru-destructor.It should be redesigned on the principles of poka-yoke whether to prevent the balloon to inflate that much or the line port connected to balloon should have warning label attached to it.I am sure hundred of women had this destructive experience all around the world.Please do something about it.Fda safety report id# (b)(4).

• Brand Name: RUMI II KOH-EFFICIENT
• Type of Device: CULDOSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): COOPERSURGICAL, INC.; trumbull CT
• MDR Report Key: 15649925
• MDR Text Key: 302245214
• Report Number: MW5112764
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 35 YR
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian