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

Model Number	B5SHF
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter during the insertion of the trocar in a procedure, the cannula broke, blue trocar particles were disseminated in the patient's abdominal cavity and could not be recovered in their entirety.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device and one photograph of a device.A visual inspection of the returned photo noted: the photo depicts the top of the trocar and cannula.The cannula appears to be broken.A visual inspection of the returned product noted: the distal end of the bladed obturator was gouged.The trocar, cannula, duckbill and circular seals appeared intact.A functional evaluation found that the device passed an air leak test.The cannula tip was checked with a 221.Pin gauge and was in spec.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.Replication of the gouged distal end of the obturator 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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter during the insertion of the trocar in a laparoscopic appendectomy, the cannula broke, blue trocar particles were disseminated in the patient's abdominal cavity, the particles were aspirated but could not be recovered in their entirety.

• Brand Name: VERSAONE
• 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: 8331284
• Report Number: 9612501-2019-00229
• Device Sequence Number: 13464441
• Product Code: GCJ
• UDI-Device Identifier: 10884521539815
• UDI-Public: 10884521539815
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: B5SHF
• Device Catalogue Number: B5SHF
• Device Lot Number: J8A0181X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Initial Date Received by Manufacturer: 01/18/2019
• Supplement Date Received by Manufacturer: 02/24/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other