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	09/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
When surgeon activated the battery powered maxtack tacker to expel a test tack onto the mayo stand, the tacker did not turn off.It continued expelling tack after tack until all 30 were expelled onto the mayo stand.It continued running.Meanwhile, the battery powered tacker motor is still running.Circulator had to removed batteries to get it to turn off.The batteries were extremely hot.The tacks were collected from the field, placed in plastic bag, and also put back in original packaging with tacker (a couple of tacks fell on floor and were not recovered).The malfunctioning tacker had no contact with the patient at any time.

• 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: 23390094
• Report Number: 23390094
• Device Sequence Number: 10047641
• Product Code: OCW
• UDI-Device Identifier: 10884521826267
• UDI-Public: (01)10884521826267(17)280430(10)N5E1686UY
• 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): 09/30/2025
• Report Date (Section F): 09/30/2025

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: MAXTACK30
• Device Lot Number: N5E1686UY
• 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: 10/27/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/27/2025
• 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: 44 YR
• Patient Sex: Female
• Patient Weight: 109 KG
• Date Report Sent to FDA: 09/30/2025