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

Model Number G19012

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/24/2022

Event Type  malfunction  

Event 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
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 15797126
• MDR Text Key: 303638370
• Report Number: 15797126
• Device Sequence Number: 1
• Product Code: LKF
• UDI-Device Identifier: 00827002190122
• UDI-Public: 00827002190122
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 11/02/2022
• Event Location: Other
• Date Report to Manufacturer: 11/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1