FDA Adverse Event Malfunction Summary report: N

HYDROSEAL

MDR report key: 22725585 · Received August 6, 2025

Report

Report Number: 3007216334-2025-00001
Event Type: Malfunction
Date Received: August 6, 2025
Date of Event: July 8, 2025
Report Date: August 6, 2025
Manufacturer: T.A.G. MEDICAL PRODUCTS CORPORATION, LTD
Product Code: GEA
Product Problem: Yes
Report Source: Distributor report
Reporter Location: MD, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE MANUFACTURER, T.A.G. MEDICAL PRODUCTS CORPORATION LTD. IS RESPONSIBLE FOR PERFORMING THE EVALUATION, INVESTIGATION AND ANY REMEDIAL ACTIONS RELATED TO THIS REPORTED DEVICE ISSUE. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

Description of Event or Problem · 0

VOLUNTARY DISTRIBUTOR REPORT A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE HS-0830, HYDROSEAL SILICONE CANNULA 8X30 MM, QTY 5 DEVICE WAS USED IN A SHOULDER ARTHROSCOPY, ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025, AND ¿THE TWO FLAPS OF THE CANNULA RIPPED OFF UPON INSERTION¿. FURTHER ASSESSMENT FOUND THE FLAPS FRAGMENTED OFF THE DEVICE AND INTO THE SURGICAL SITE, AND "ALL FRAGMENTS (2) WERE RETRIEVED" USING A GRASPER AND HEMOSTAT. THE PROCEDURE WAS COMPLETED AS NORMAL WITH THE USE OF AN ALTERNATE SAME DEVICE AND A DELAY OF ¿3-5 MINUTES TO RETRIEVE THE FRAGMENTED PIECES¿. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1569213	HYDROSEAL	CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY	GEA	T.A.G. MEDICAL PRODUCTS CORPORATION, LTD		24P03

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown