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

Model Number	S101005
Medical Device Problem Codes	Break (1069); Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2018
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, at the beginning of the case, as soon as scope entered trocar, the obtura tor/trocar broke.The coating inside the cannula flaked off.They grabbed a new trocar to resolve the issue in order to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Additional info: evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection noted: that the trocar, cannula and circular seal appeared intact.The radially expandable sleeve and obturator were not received.A functional evaluation found that the device passed an air leak test.The cannula tip was checked with a 221.Pin gauge and was in spec.An ethicon ligamax and a stryker strykeflow ii were used to test for resistance by inserting and removing into the cannula no resistance was noted.The distal end of the cannula was checked and inside showed signs of scratches and coating missing.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 scratches inside the cannula may occur when mishandled during clinical application.The root cause of the observed damage was misuse of the product 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: 7911272
• Report Number: 2647580-2018-04719
• Device Sequence Number: 19336545
• Product Code: GCJ
• UDI-Device Identifier: 20884521090733
• UDI-Public: 20884521090733
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K950632
• 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): 12/28/2018

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: 01/31/2023
• Device Model Number: S101005
• Device Catalogue Number: S101005
• Device Lot Number: P8A0008X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 78