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

Model Number	G19012
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Patient called in this morning to inform staff that a "little rubber acorn shaped object fell out of her" and she was concerned it was left behind from the hsf procedure and was worried more may be left behind.

• Brand Name: GOLDSTEIN SONOHYSTEROGRAPHY CATHETER
• Common Device Name: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 15797126
• Report Number: 15797126
• Device Sequence Number: 14621192
• Product Code: LKF
• UDI-Device Identifier: 00827002190122
• UDI-Public: 00827002190122
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 11/02/2022
• Report Date (Section F): 11/02/2022

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: G19012
• Device Catalogue Number: J-GSHC-542600-SV
• Device Lot Number: 14710454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 11/15/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/02/2022