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

Model Number	017617
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	03/08/2019
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 a left upper lobectomy when isolating the lung tissue, the surgeon was able to press the green button but was not able squeeze the handle and therefore the laparoscopic stapler did not fire.The procedure was converted to open procedure and 2 open staplers of the same lot was used however there was poor staple line formation, the staple line was scattered and unformed.Another device was used to complete the case.
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: 8462367
• Report Number: 2647580-2019-01700
• Device Sequence Number: 11473064
• Product Code: GDW
• UDI-Device Identifier: 10884521047723
• UDI-Public: 10884521047723
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K855047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2019

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: 01/31/2021
• Device Model Number: 017617
• Device Catalogue Number: 017617
• Device Lot Number: P6A0250X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 04/05/2019
• 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
• Patient Age: 50 YR