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

Model Number	S100712
Medical Device Problem Codes	Break (1069); Difficult to Insert (1316); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2019
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, on a laparoscopic procedure, when the surgeon placed the device into the left chest.It did not go in easily and the skin incision was extended.The device functioned as intended for the duration of the procedure.However, at the conclusion of the case, when the surgeon pulled the port to remove it from the chest wall, the gray shaft of the port broke into two pieces.Both pieces were retrieved and there was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted that the trocar, obturator radially expandable sleeve appeared intact.The cannula was broken in two pieces.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Replication of the broken cannulas may occur when mishandled during clinical application.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, on a laparoscopic procedure, when the surgeon placed the device into the left chest.It did not go in easily and the skin incision was extended by 1-2 mm.The device functioned as intended for the duration of the procedure.However, at the conclusion of the case, when the surgeon pulled the port to remove it from the chest wall, the gray shaft of the port broke into two pieces.Both pieces were retrieved and there was no patient injury.

• 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: 8405053
• Report Number: 2647580-2019-01245
• Device Sequence Number: 389604
• Product Code: GCJ
• UDI-Device Identifier: 20884521090672
• UDI-Public: 20884521090672
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/23/2019

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: 09/30/2021
• Device Model Number: S100712
• Device Catalogue Number: S100712
• Device Lot Number: P8J1593X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 05/04/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1