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

Model Number	S100712
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2019
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 laparoscopic procedure, when the obturator and cannula was being inserted into the radially expanding sleeve through the abdominal wall the distal tip of the device broke off and disengaged into the patient's cavity.This was retrieved using a laparoscopic grasper.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one device.The visual inspection of the returned photo noted: the image depicts the product identification label in a bag.There is a bio-hazard sticker on the bag.There is a disengaged piece of radially expandable sleeve in the bag with a circle drawn around it.Without the physical device all functional evaluation is precluded.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparoscopic procedure, when the obturator and cannula was being inserted, the distal tip of the device broke off the radially expanding sleeve through the abdominal wall and disengaged into the patient's cavity.This was retrieved using a laparoscopic grasper.Same device was used to complete the case.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: 9417090
• Report Number: 2647580-2019-05920
• Device Sequence Number: 16276998
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2019

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: 06/30/2022
• Device Model Number: S100712
• Device Catalogue Number: S100712
• Device Lot Number: P9G0702Y
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 12/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1