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

Model Number	017614
Medical Device Problem Codes	Failure to Form Staple (2579); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/29/2019
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 open tumor resection procedure, while using the device to close the intestine by going down the distal of the tumor which was located on the rectum, the staple line was incomplete and there was poor staple formation.The staples fell into the cavity of the patient and it was retrieved with suction/irrigation device.Resecting and re-stapling using new device was done to fixed the staple line.
Additional Manufacturer Narrative
Evaluation summary: 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 was reloaded with staples and applied to test media.The staple line was properly formed, and the jaw properly clamped and unclamped when the approximating lever was operated.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: 8660722
• Report Number: 2647580-2019-02799
• Device Sequence Number: 2286124
• Product Code: GDW
• UDI-Device Identifier: 20884521047706
• UDI-Public: 20884521047706
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2019

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: 09/30/2022
• Device Model Number: 017614
• Device Catalogue Number: 017614
• Device Lot Number: P7J0908X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 08/12/2019
• 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