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

Model Number	MAXTACK30
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was brought to the operating room and placed supine on the operating table.Time out was performed and general anesthesia was given.Excerpts from surgeon's notes: attention was next directed at repair.The absorbable laparoscopic tacking device was used to circumferentially tack the mesh into place.Issue: maxtack not firing.The device was changed with another device and the procedure was done without further incident.

• 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: 25731867
• Report Number: 25731867
• Device Sequence Number: 21447533
• Product Code: OCW
• UDI-Device Identifier: 10884521826267
• UDI-Public: (01)10884521826267(17)270813(10)N5B1138UY
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/27/2026
• Report Date (Section F): 05/27/2026

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: N5B1138UY
• 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: 07/07/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/07/2026
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Date Report Sent to FDA: 05/27/2026