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

Model Number	RELTACK8RDPT
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during laparoscopic inguinal procedure, the devices disengaged into the cavity of the patient.Reload fell into the patient while tacking the mesh in place.Reload was taken out in order to complete the case.There was no injury to the patient and no medical intervention was required.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the device was noted a tack was protruding and the timing was disengaged.Additionally, microscopic inspection noted scratches on the inner tube and the outer edge was dented.The dependent logical unit (dlu) could not be loaded onto a test device due to the disrupted timing and the damaged outer edge of the dependent logical unit (dlu).Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all manufacturers¿ quality release specifications at the time of manufacture.Replication of the reported conditions could be due to improper loading of the reloads, indicated by the scratches on the inner tube of the reloads.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection noted a tack was protruding and the timing was disengaged.Additionally, microscopic inspection noted scratches on the inner tube and the outer edge was dented.The dlu (device loading unit) could not be loaded onto a test device due to the disrupted timing and the damaged outer edge of the dlu.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the reported conditions could be due to improper loading of the reloads, indicated by the scratches on the inner tube of the reloads.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during laparoscopic inguinal procedure, the devices disengaged into the cavity of the patient and was retrieved by using a laparoscopic alice.Reload fell into the patient while tacking the mesh in place.Reload was taken out in order to complete the case.There was no injury caused to the patient and no medical intervention was required.

• 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: 7374170
• Report Number: 1219930-2018-01711
• Device Sequence Number: 2311821
• Product Code: GDW
• UDI-Device Identifier: 10884521202375
• UDI-Public: 10884521202375
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K151659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2018

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 Expiration Date: 02/29/2020
• Device Model Number: RELTACK8RDPT
• Device Catalogue Number: RELTACK8RDPT
• Device Lot Number: N7B0615UX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 03/30/2018; 05/18/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 04/17/2018; 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1