MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD "VERSAONE¿ BLADED TROCAR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	B12STS
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter: occurred during a laparoscopic procedure.The obturator / trocar broke.The blade failed to deploy.In order to resolve the issue and complete the case, another access port was used.There was no patient harm.The patient status is alive, no injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: "VERSAONE¿ BLADED TROCAR
• 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: 6453996
• Report Number: 9612501-2017-05257
• Device Sequence Number: 1378489
• Product Code: GCJ
• UDI-Device Identifier: 10884521539884
• UDI-Public: 10884521539884
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K151548
• 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,Followup
• Report Date (Section B): 03/10/2017

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: 10/31/2020
• Device Model Number: B12STS
• Device Catalogue Number: B12STS
• Device Lot Number: J5K1073X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2017
• Supplement Date Received by Manufacturer: 03/10/2017
• Initial Report FDA Received Date: 04/03/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1