MAUDE Adverse Event Report: US SURGICAL PUERTO RICO STEP; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	S100712
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2019
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 laparoscopic procedure, while insertion of device into the abdominal wall, a piece of the sleeve came off and ended up inside the patient.It is the plastic tip that covers the expandable sleeve itself (it's not the sheath that comes over the sleeve, it's the piece on the sleeve itself that keeps the expandable fibers together).The surgeon was able to retrieve all plastic parts from the abdomen prior to continuing with the procedure using a laparoscopic grasper.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) received a photographic investigation of the device.The first photo depicts the radially expandable sleeve the distal end of the cannula was disengaged.The second photo depicts the frayed end of the radially expandable sleeve.Post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted that the trocar, circular seal and obturator appeared intact.The radially expandable sleeve the distal end of the cannula was broken.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the cut in the circular seal may occur when mishandled during clinical application.The root cause of the observed damage was due to the product not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEP
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 8776238
• Report Number: 2647580-2019-03590
• Device Sequence Number: 2102960
• Product Code: GCJ
• UDI-Device Identifier: 20884521090672
• UDI-Public: 20884521090672
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K961430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2019

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: 03/31/2022
• Device Model Number: S100712
• Device Catalogue Number: S100712
• Device Lot Number: P9D1540Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 10/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1