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

Model Number S100000

Device Problems Dull, Blunt (2407); Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/30/2017

Event Type  malfunction  

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 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
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6897718
• MDR Text Key: 87512229
• Report Number: 9612501-2017-06268
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20884521090825
• UDI-Public: 20884521090825
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K961940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2017
• Initial Date FDA Received: 09/27/2017
• Date Device Manufactured: 03/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1