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

Model Number	RELTACK8RDPTSW
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687); Radiation Exposure, Unintended (3164); No Code Available (3191); Constipation (3274)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: health professional (hpro).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, post-operatively, the device was in the articulated position when it was removed from the trocar and the reload fell off and was left in the abdomen without notice.The patient came back to operating room a day after laparoscopic ventral surgery with constipation and pain.The symptoms did not subside so patient had an x-ray and foreign object was found in the patient.The object was the reload.The surgeon completed a second surgery to remove the object.The event led to extended patient hospitalization for one day.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: RELIATACK
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven 06473
• MDR Report Key: 7722929
• Report Number: 1219930-2018-04110
• Device Sequence Number: 849045
• Product Code: GDW
• UDI-Device Identifier: 20884521726359
• UDI-Public: 20884521726359
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2018

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 Model Number: RELTACK8RDPTSW
• Device Catalogue Number: RELTACK8RDPTSW
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention