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

Lot Number 315285

Device Problems Material Fragmentation (1261); Melted (1385)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/16/2022

Event Type  malfunction  

Event Description

Rumi instrument used during hysterectomy for uterine manipulation was melted with harmonic in process.Small flakes from end of rumi found floating in specimen container and some pieces of rumi were removed from patient during case by doctor.

• Brand Name: RUMI II KOH-EFFICIENT
• Type of Device: CULDOSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): COOPERSURGICAL, INC.
• MDR Report Key: 15426782
• MDR Text Key: 299944604
• Report Number: 15426782
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 315285
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/06/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16060 DA
• Patient Sex: Female
• Patient Race: White