MAUDE Adverse Event Report: CATHETER RESEARCH, INC./THOMAS MEDICAL INC.; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Model Number TMI1151

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2017

Event Type  malfunction  

Event Description

During a laparoscopy procedure, an approximately 1-inch plastic tip of a disposable uterine manipulator broke off in a patient's cervix while in use by the proceduralist.

• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CATHETER RESEARCH, INC./THOMAS MEDICAL INC.; 6102 victory way; indianapolis IN 46278
• MDR Report Key: 6857845
• MDR Text Key: 85802890
• Report Number: 6857845
• 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: 08/01/2017,08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/01/2021
• Device Model Number: TMI1151
• Device Catalogue Number: TMI1151
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/01/2017
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 08/01/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES; NO, ONLY A TENACULUM ON THE ANTERIOR LIP OF CERVIX
• Patient Age: 31 YR
• Patient Weight: 48