MAUDE Adverse Event Report: CATHETER RESEARCH, INC. ZINNANTI MANIPULATOR; CANNULA, MANIPULATOR, INJECTOR, UTERINE

Model Number	TMI1151
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Very rare occurrence.A review of the returned device piece confirmed the clean break.A clean break can be the result of scoring of some type to the shaft or stress cracking on the shaft.Each device is tested and inspected for stress cracking prior to release.A review of the risk documents for using the device does show that the device breaking can also be caused by over manipulation.With the limit amount of information known on the robotic procedure, it is very difficult to determine the true cause of this fracture.The risk assessment performed on this device also indicate that such failure (clean shaft snap in the vagina) will result in nuisance to the user and is unlikely to cause any serious injury.A review of the instructions for use included with the device shows the last step is to remove the device and verify that the entire device was removed intact and nothing remains behind in the patient.
Event or Problem Description
Description from the user- facility: "the user facility reported on (b)(6) 2016 that the patient's spouse called to report that the patient felt a plastic piece in vagina.Reported a four inch small plastic piece was removed.Surgeon was called and he contacted the patient.Spoke with or and said it was most likely from the humi (sic) uterine manipulator.Spoke with patient.Met them at surgeon's office, and they presented the piece which has been removed.The piece was a segment of the uterine manipulator.Patient instructed to observe for any other changes, signs, or symptoms and to call with any questions and concerns.The original intended procedure was robotic surgery for ovarian cyst.".

• Brand Name: ZINNANTI MANIPULATOR
• Common Device Name: CANNULA, MANIPULATOR, INJECTOR, UTERINE
• Manufacturer (Section D): CATHETER RESEARCH, INC.; 6102 victory way; indianapolis IN 46278
• MDR Report Key: 6513083
• Report Number: 1833117-2017-00001
• Device Sequence Number: 231931
• Product Code: LKF
• UDI-Device Identifier: 00852073002517
• UDI-Public: 00852073002517
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K974357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other,Replace
• Type of Report: Initial
• Report Date (Section B): 04/04/2017

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
• Operator of Device: Physician
• Device Expiration Date: 07/01/2021
• Device Model Number: TMI1151
• Device Lot Number: Q374D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 19.0 YR