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

Model Number	017614
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: occurred during a laparoscopic low anterior resection (lar) procedure.The stapling devices were being used for the rectum resection.The patient had undergone radiation treatments so the tissue was very thick.The patient was also obese with a very narrow pelvis.The powered stapling handle broke due to the thickness of the rectum.The surgeon forced the trigger pushing intensively.There was also a problem unloading the powered stapling device.Seems as if the axis is outside the adapter due to the extreme force the surgeon did try to place and fire the stapler with the reload.A component of the inner adapter axis broke off.Then tried to performed with resection using a manual stapling handle with another reload, but it did not work either.Then tried with a roticulator stapler, but the staple line was not continuous.Was not safe to use a circular stapler in order to perform the anastomosis.There was no patient injury.

• 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: 7371847
• Report Number: 2647580-2018-01520
• Device Sequence Number: 39655
• Product Code: GDW
• UDI-Device Identifier: 10884521047709
• UDI-Public: 10884521047709
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Report Date (Section B): 03/26/2018

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 Model Number: 017614
• Device Catalogue Number: 017614
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 03/26/2018
• 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: Other