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

Model Number	S100000
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/08/2019
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, preoperatively, the surgeon stated that the insufflation needle was difficult to engage/move forward into the dilator.It was felt that it gets stuck.There was no patient involvement.

• 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: 8552544
• Report Number: 9612501-2019-00864
• Device Sequence Number: 16221751
• Product Code: GCJ
• UDI-Device Identifier: 20884521090825
• UDI-Public: 20884521090825
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K961940
• 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): 04/25/2019

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 Expiration Date: 04/30/2023
• Device Model Number: S100000
• Device Catalogue Number: S100000
• Device Lot Number: J8D0024X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1