MAUDE Adverse Event Report: COOK INCORPORATED GOLDSTEIN; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Model Number	G17149
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The patient underwent a sono-hysterogram using a goldstein catheter.At the time of the catheter removal, the white plastic positioner catheter tip was not removed at the same time that the catheter was removed and remained in the patient's vagina.The patient self-removed the positioner catheter tip later after the procedure and notified the physician.Concern has been raised that this product is comprised of two pieces that can be separated and have no safety mechanism to keep the two pieces together and that there are products that do not separate that may be safer for patients.

• Brand Name: GOLDSTEIN
• Common Device Name: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10178355
• Report Number: 10178355
• Device Sequence Number: 19603412
• Product Code: LKF
• UDI-Device Identifier: 00827002171497
• UDI-Public: (01)00827002171497(17)230217(10)10333047
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2020
• Report Date (Section F): 06/12/2020

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: Health Professional
• Device Model Number: G17149
• Device Catalogue Number: J-GSHC-532600
• Device Lot Number: 10333047
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/22/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/12/2020