MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. SEROSAFUSE IMPLANTABLE FASTENER KIT; HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL

Catalog Number	R2275
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.The complaint cannot be confirmed and a root cause cannot be determined.A review of the device history record and complaint database cannot be performed as a lot number was not provided.
Event or Problem Description
The account alleges a patient entered the er 6 days post-op on (b)(6) 2025 with abdominal pain.The patient was admitted to the hospital.Ct scan same day showed approximately 2x2cm collection of air and oral contrast proximal to gej in abdomen, they noted concern for contained esophageal perforation.The patient was placed on pain meds, abx and antifungal.The patient required 3 units of blood transfused.They performed egd on (b)(6), found bleeding in stomach, close to gej though exact source of bleeding was indeterminate.Endoclot powder was spread over gefv.Stent was placed across gej.Subsequent ct scan ordered showed 2.6x2.3cm collection of air and oral contrast in abdomen proximal to gej in abdomen, bleeding in the anterior lesser curvature of the stomach, and noted a small pleural effusion.2nd egd showed stent had migrated and it was subsequently removed.Cautery was used on the lip of the gefv at approximately the 5 o'clock location where bleeding was noted, clip was placed in this location.They have characterized this as a leak at the gej - theorizing the small leak was along the path of a serosa fuse fastener - and not due to an esophageal perforation.No additional patient consequence to report.

• Brand Name: SEROSAFUSE IMPLANTABLE FASTENER KIT
• Common Device Name: HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 22810243
• Report Number: 1721504-2025-00257
• Device Sequence Number: 5791067
• Product Code: EGS
• UDI-Device Identifier: 00810275014011
• UDI-Public: 00810275014011
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: R2275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown