MAUDE Adverse Event Report: SURGICAL PRODUCT SOLUTIONS / COOPERSURGICAL, INC. RUMI KOH- EFFICIENT, 3.5 CM; CULDOSCOPE (AND ACCESSORIES)

Lot Number 332967

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

Event Date 09/19/2023

Event Type  malfunction  

Event Description

The round end of the rumi broke off during removal of the uterus from the vagina.All pieces were intact.No fragments of disposable left in patient.Disposable is sequestered and given to supply chain specialist.

• Brand Name: RUMI KOH- EFFICIENT, 3.5 CM
• Type of Device: CULDOSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): SURGICAL PRODUCT SOLUTIONS / COOPERSURGICAL, INC.
• MDR Report Key: 17836564
• MDR Text Key: 324661759
• Report Number: MW5146260
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 332967
• 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: 53 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Hispanic