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

Model Number	017614
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Codes	Tissue Damage (2104); No Code Available (3191)
Date of Event	10/11/2019
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 a laparoscopic rectum celio conversion procedure, during firing the surgeon cut the rectum thinking staples had been deployed, but upon opening it was noted that there was none.A new device was used to complete the procedure.The patient's hospital stay was extended for 15 days.The surgeon lost estimated 2.5 cm of tissue on the distal part of the rectum and there was tissue damage.

• 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: 9371861
• Report Number: 2647580-2019-05774
• Device Sequence Number: 2197340
• Product Code: GDW
• UDI-Device Identifier: 10884521047709
• UDI-Public: 10884521047709
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 11/25/2019

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: 09/30/2023
• Device Model Number: 017614
• Device Catalogue Number: 017614
• Device Lot Number: P8J1183X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 11/25/2019
• 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: Other; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 65