MAUDE Adverse Event Report: C R I; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Model Number UTERINE MANIPULATOR

Device Problems Break (1069); Component Falling (1105)

Patient Problem No Code Available (3191)

Event Date 02/14/2018

Event Type  malfunction  

Event Description

Uterine manipulator broke off while inside patient.Manipulator broke into 2 pieces, both pieces were removed from patient and it was determined that no remaining pieces were in patient.

• Brand Name: NA
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): C R I; 6102 victory way; indianapolis IN 46278
• MDR Report Key: 7320095
• MDR Text Key: 101784340
• Report Number: 7320095
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: UTERINE MANIPULATOR
• Device Catalogue Number: TMI1151
• Device Lot Number: U691C
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES