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 Code Available (3191)
Date of Event	10/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during an open thoracotomy upper and middle lobectomy procedure, the device fired but did not deploy any staples.To resolve the issue the surgeon sutured the bronchus to closed.
Additional Manufacturer Narrative
Additional info: if information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: evaluation summary: post market vigilance (pmv) led an evaluation of one device.The device was received fully applied.The pushers were advanced.The handle was locked.Functionally; the head articulated.The locking collar functioned properly.The jaw clamped and unclamped when the approximating lever was lowered and raised.Microscopic evaluation of the pusher noted deformation indicating the staples were present and deployed.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.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: 8094863
• Report Number: 2647580-2018-05661
• Device Sequence Number: 16842023
• Product Code: GDW
• UDI-Device Identifier: 10884521047723
• UDI-Public: 10884521047723
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K855047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/24/2019

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 Expiration Date: 01/05/2019
• Device Model Number: 017617
• Device Catalogue Number: 017617
• Device Lot Number: P4E0426X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 12/04/2018; 01/03/2019
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 12/28/2018; 01/24/2019
• 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: Required Intervention