MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD 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)
Date of Event	10/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led a photographic evaluation of three photographs of the devices.A visual inspection of the returned photos noted: the first photo depicts a full view of the device inside a sample bag.The second photo depicts a patient identification label on the bag.The third 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 laparoscopic procedure, the device rubber center to step port fell into the patient cavity during surgical procedure, and was then was recovered.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led a photographic evaluation of three photographs of the device and the device.A visual inspection of the returned photos noted: the first photo depicts a full view of the device inside a sample bag.The second photo depicts a patient identification label on the bag.The third photo depicts the circular seal inside the bag.A visual inspection of the returned product noted: the circular seal was cut.The trocar, cannula and envelope seal appeared intact.The obturator and expandable sleeve was not received.A functional evaluation found that the device passed 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.
Event or Problem Description
According to the reporter, during laparoscopic appendectomy procedure, the device rubber center to step port fell into the patient cavity during surgical procedure, and was then was recovered.There was no patient injury.

• Brand Name: MINI STEP
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 8084364
• Report Number: 9612501-2018-02056
• Device Sequence Number: 13852725
• 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
• 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: 12/18/2018
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR