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

Model Number	MS101008
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2018
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, the sheath ripped when the surgeon pulled out the verress needle, not really a damaged seal but a ripped sheath.It was replaced with a new one to complete the case.There was no patient injury.

• Brand Name: MINI 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: 8101643
• Report Number: 2647580-2018-05710
• Device Sequence Number: 1191049
• Product Code: GCJ
• UDI-Device Identifier: 20884521082745
• UDI-Public: 20884521082745
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K961430
• 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): 11/26/2018

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: 04/30/2021
• Device Model Number: MS101008
• Device Catalogue Number: MS101008
• Device Lot Number: P8D1297X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 11/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1