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

Model Number	017612
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter: occurred during an open low anterior resection / double stapling procedure.For the first firing, the surgeon clamped the tissue of the rectum and fully fired the device.Then removed the device from the tissue, however, noticed a part of the jaws was cracked.There was no problem with the stapling.Then the anastomosis was performed and the procedure was completed with no problem.There was no patient harm.The status of the patient is no problem.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Investigation 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.The blue collar at the distal end broke off the shaft.Functionally; the instrument was found to function as intended.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Replication of the observed condition may occur if the instrument is dropped or impacted during clinical application causing the component to break.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.

• 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: 6976393
• Report Number: 2647580-2017-07352
• Device Sequence Number: 1156251
• Product Code: GDW
• UDI-Device Identifier: 10884521047693
• UDI-Public: 10884521047693
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K855047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2018

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: 06/30/2018
• Device Model Number: 017612
• Device Catalogue Number: 017612
• Device Lot Number: P3F0647X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Initial Date Received by Manufacturer: 10/20/2017
• Supplement Date Received by Manufacturer: 01/08/2018; 02/08/2018
• Initial Report FDA Received Date: 10/25/2017
• Supplement Report FDA Received Date: 01/25/2018; 02/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1