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

Model Number	017617
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2018
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 lower anterior resection, while performing resection of colon, the staples of the device did not deploy.There was no patient injury.
Additional Manufacturer Narrative
Additional: the incident device has been received and is under evaluation.When the device evaluation is complete a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during lower anterior resection, while performing resection of colon, the staples of the device did not deploy.They took another device to resolve the issue and complete the case.There was no patient injury.
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of one device.The instrument was received fully applied.The unformed staples were ex posed.The approximation lever was closed.The handle was locked.The cable was broken.The condition of the instrument precludes functional evaluation.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Replication of the observed condition may occur when the approximation lever is not properly closed prior to cycling the firing handle damaging the firing cable.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during lower anterior resection, while performing resection of colon, there was no possibility to fire stapler and it not deploy.They took another device to resolve the issue and complete the case.There was no patient injury.
Additional Manufacturer Narrative
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: 7476094
• Report Number: 2647580-2018-02213
• Device Sequence Number: 1768822
• Product Code: GDW
• UDI-Device Identifier: 10884521047723
• UDI-Public: 10884521047723
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/03/2018

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: 09/30/2022
• Device Model Number: 017617
• Device Catalogue Number: 017617
• Device Lot Number: P7J0899X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Initial Date Received by Manufacturer: 04/23/2018
• Supplement Date Received by Manufacturer: 07/02/2018; 08/02/2018; 08/08/2018
• Initial Report FDA Received Date: 05/01/2018
• Supplement Report FDA Received Date: 07/23/2018; 08/27/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1