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

Model Number	ONB12STFCS
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Unspecified Tissue Injury (4559)
Date of Event	02/03/2021
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, a closure trocar was used for incisional wound closure of the 12 mm trocar during abdominal incisional hernia, there was air or gas leakage from the seal, 4 days after being discharged from the hospital, the patient went through an emergency treatment due to abdominal pain.The fascia was found not properly picked up by the thread of the closure trocar, which had been placed with the hernia from the 12mm port wound.A 5 cm incision was made as an emergency procedure, and the fascia was closed under direct vision.

• 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 ; DR 0101
• MDR Report Key: 11395612
• Report Number: 9612501-2021-00327
• Device Sequence Number: 16435801
• Product Code: GCJ
• UDI-Device Identifier: 10884521678712
• UDI-Public: 10884521678712
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K163654
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2021

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: ONB12STFCS
• Device Catalogue Number: ONB12STFCS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 03/01/2021
• 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: Required Intervention