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

Model Number	179078PF
Medical Device Problem Codes	Difficult to Insert (1316); Packaging Problem (3007)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
Date of Event	09/24/2018
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, pre-operatively, the obturator/trocar broke.The problem has been noticed on several trocars from the same batch.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.A visual inspection of the returned product noted: the obturator was received inserted into the cannula.Prolonged insertion can cause the envelope seal to become stretched.The obturator, trocar, cannula and circular seal appeared intact.The envelope seal was badly stretched out.A functional evaluation found that the device failed an air leak test.The bladed trocar would not actuate.Review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, intra-operatively, the surgeon could not insert the trocar because it was locked in safety position.It was also reported that the blade could not perforate the patient¿s abdomen, and the trocar could not be inserted.

• Brand Name: VERSAPORT PLUS
• 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: 8034599
• Report Number: 9612501-2018-01931
• Device Sequence Number: 1435422
• Product Code: GCJ
• UDI-Device Identifier: 20884521082684
• UDI-Public: 20884521082684
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K062326
• 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,Followup
• Report Date (Section B): 03/25/2019

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: 06/30/2023
• Device Model Number: 179078PF
• Device Catalogue Number: 179078PF
• Device Lot Number: J8F1135X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1