MAUDE Adverse Event Report: COOPERSURGICAL, INC. KOH-EFFICIENT,RUMI,4.0CM

Model Number KC-RUMI-40

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/12/2022

Event Type  malfunction  

Event Description

Rumi cup broke off in patient, they were able to remove cup vaginally.Did the incident occur before, during, or after a procedure: during additional information: the patient is fine and was asleep when this happened.The device needs to stay within the hospital as they are doing an investigation.This is an isolated event.Koh-efficient,rumi,4.0cm kc-rumi-40 (b)(4).

Manufacturer Narrative

Coopersurgical , inc.Is currenlty investigating the condition reported.

• Brand Name: KOH-EFFICIENT,RUMI,4.0CM
• Type of Device: KOH-EFFICIENT,RUMI,4.0CM
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC,; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 15293187
• MDR Text Key: 303707432
• Report Number: 1216677-2022-00248
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: KC-RUMI-40
• Device Catalogue Number: KC-RUMI-40
• Device Lot Number: 310088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other