MAUDE Adverse Event Report: COVIDIEN LP MAXTACK; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number	MAXTACK30
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Failed during use, failed to fire.

• Brand Name: MAXTACK
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN LP; 60 middletown ave; north haven CT 06473
• MDR Report Key: 24980112
• Report Number: 24980112
• Device Sequence Number: 15877741
• Product Code: OCW
• UDI-Device Identifier: 10884521826267
• UDI-Public: (01)10884521826267(17)280731(10)N5J1358UY
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 04/20/2026
• Report Date (Section F): 04/20/2026

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: MAXTACK30
• Device Lot Number: N5J1358UY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 156 KG
• Date Report Sent to FDA: 04/20/2026