MAUDE Adverse Event Report: MICRO-TECH (NANJING) CO., LTD. SURECLIP(®) REPOSITIONABLE HEMOSTASIS CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number	ROCC-D-26-235-C-N
Health Effect - Clinical Codes	Embolism/Embolus (4438); Gastrointestinal Hemorrhage (4476); Stomach Ulceration (4488)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient presented to endoscopy department as a transfer from intensive care for an egd [esophagogastroduodenoscopy] colonoscopy for gib [gastrointestinal bleeding].Upon entering stomach with endoscope, patient's stomach was found to contain old blood and food debris, which were removed.Upon advancing further, patient's duodenal bulb was found to contain a large ulcer with a visible blood vessel (not actively bleeding).Epinephrine was injected into ulcer, followed by electrocautery being administered.One hemostasis clip was deployed with no problem, but the second clip mis-deployed.After this, blood began to stream out of ulcer.Various methods of treatment were used until hemostasis was achieved.Gi called cvir [cardiovascular interventional radiology] department to alert them of situation and make sure they were ready to take patient for embolization.Patient remained intubated and was transported from endoscopy to cvir with this rn, anesthesia resident.Udi-di number: (01)06932503530446(17)270616(10)m240617231.

• Brand Name: SURECLIP(®) REPOSITIONABLE HEMOSTASIS CLIP
• Common Device Name: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): MICRO-TECH (NANJING) CO., LTD.; 2855 broadway dr; ann arbor MI 48104
• MDR Report Key: 22183365
• Report Number: 22183365
• Device Sequence Number: 20986995
• Product Code: PKL
• UDI-Device Identifier: 06932503530446
• UDI-Public: (01)06932503530446
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/03/2025
• Report Date (Section F): 06/03/2025

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: ROCC-D-26-235-C-N
• Device Lot Number: M240617231
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 06/11/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2025
• 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 Age: 50 YR
• Patient Sex: Male
• Patient Weight: 112 KG
• Date Report Sent to FDA: 06/03/2025