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

Model Number	MS101005
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Post market vigilance (pmv) led a photographic evaluation of two photographs of a device.A visual inspection of the returned photos noted: the first photo depicts a patient identification label on the bag.The second photo depicts the circular seal inside the bag.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, the rubber gasket/seal of the device disengaged and fell into the patient's cavity, it was retrieved.There was no injury.
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 appendectomy procedure, the rubber gasket/seal of the device disengaged and fell into the patient's cavity, it was retrieved by using a grasper.No injury.
Additional Manufacturer Narrative
Additional information: evaluation summary: post market vigilance (pmv) led an evaluation of two devices.A visual inspection of the returned products noted: the obturator was received inserted into the cannula, prolonged insertion can cause the envelope seal to become stretched.The circular seals were cut.A functional evaluation found that the devices failed an air leak test.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 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: 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: 8083992
• Report Number: 2647580-2018-05619
• Device Sequence Number: 1771157
• Product Code: GCJ
• UDI-Device Identifier: 20884521082738
• UDI-Public: 20884521082738
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 02/01/2019

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 Model Number: MS101005
• Device Catalogue Number: MS101005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 11/11/2018; 01/10/2019
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 12/06/2018; 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1