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

Model Number	ONB12STF
Medical Device Problem Codes	Break (1069); Decrease in Pressure (1490); Noise, Audible (3273)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/26/2021
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 a laparoscopic bypass, the instrument made strange noise and due to entering of different size of devices, the seal first was extended and then broke.It was noted that the surgical time was extended by more than 30 minutes due to the rapid loss of pneumoperitoneum.A new trocar was used to resolve the issue.
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 a laparoscopic bypass, the five instruments made strange noise and due to entering of different size of devices, the seal first was extended and then broke.It was noted that the surgical time was extended by more than 30 minutes due to the rapid loss of pneumoperitoneum.A new trocar was used to resolve the issue.

• Brand Name: VERSAPORT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• MDR Report Key: 12465619
• Report Number: 9612501-2021-01509
• Device Sequence Number: 17092219
• Product Code: GCJ
• UDI-Device Identifier: 10884521181335
• UDI-Public: 10884521181335
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K130435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2021

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 Model Number: ONB12STF
• Device Catalogue Number: ONB12STF
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 09/29/2021
• 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