MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ROTICULATOR; STAPLE, IMPLANTABLE

Model Number	017614
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2018
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 a low anterior resection surgery, the device did not fire.They used another stapler to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of one device.There were no visual or functional abnormalities noted during pmv testing.The instrument was received with the pushers advanced and the handle locked.Functionally, the instrument staple pushers were reset.The jaw properly clamped and unclamped when the approximating lever was operated.The instrument functioned with acceptable results.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ROTICULATOR
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 7625028
• Report Number: 2647580-2018-03067
• Device Sequence Number: 1529527
• Product Code: GDW
• UDI-Device Identifier: 10884521047709
• UDI-Public: 10884521047709
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K855047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2018

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: 02/28/2022
• Device Model Number: 017614
• Device Catalogue Number: 017614
• Device Lot Number: P7B0047X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 06/21/2018
• Supplement Report FDA Received Date: 08/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1