MAUDE Adverse Event Report: COVIDIEN LP RELIATACK; STAPLE, IMPLANTABLE

Model Number	RELTACK3X10SW
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	11/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During laparoscopic da vinci procedure, the reliatack articulating reloadable fixation device malfunctioned.Procedural note:.Right flank hernia was found from previous lumbar fusion.This hernia defect was about 5 cm in length but in this position was about 1.5-2 cm wide.I used a 10 x 15 symbotex mesh which was inserted into the abdomen.The carter-thomason was used to grab the stitches and bring the transfixing stitches into position so that this mesh was centered and covered the defect.After this was done, it was tacked down with absorbable tacks.However, for the second time recently i had problems with this misfiring and being unable to reattach a second load of tacks.Therefore, i switched to the protacker in order to finish anchoring this mesh in position.Care was taken not to injure bowel or any abdominal structures.My transfixing stitches were cinched down.

• Brand Name: RELIATACK
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8132737
• Report Number: 8132737
• Device Sequence Number: 2325337
• Product Code: GDW
• UDI-Device Identifier: 10884521726376
• UDI-Public: (01)10884521726376(17)200930(10)N7J0600UX
• 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): 11/21/2018
• Report Date (Section F): 11/21/2018

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: RELTACK3X10SW
• Device Catalogue Number: RELTACK3X10SW
• Device Lot Number: N7J0600UX
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 80
• Date Report Sent to FDA: 11/21/2018