MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD STEP; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	S100000
Medical Device Problem Codes	Dull, Blunt (2407); Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, durwhile accessing the skin, the tip of the product was not sharp and the cannula was broken.A new product was used to complete the case.There was no patient injury.

• Brand Name: 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: 6897718
• Report Number: 9612501-2017-06268
• Device Sequence Number: 659350
• Product Code: GCJ
• UDI-Device Identifier: 20884521090825
• UDI-Public: 20884521090825
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K961940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2017

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: 03/31/2021
• Device Model Number: S100000
• Device Catalogue Number: S100000
• Device Lot Number: J6C1003X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1