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

Model Number	UNKNOWN TROCAR DEVICE
Medical Device Problem Codes	Leak/Splash (1354); Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: nonb12stf, nonb12stf no blade 12 std fix (lot#j3b0816y) unvca5stf, unvca5stf universal 5mm std fix cannula (lot#j3d0584y) nonb12stf, nonb12stf no blade 12 std fix (lot#j3k2738y); medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, intra-operatively of a laparoscopic gastric bypass, the trocars have failed to filter co2.The seals were damaged and disengaged.The devices leak air or gas.Another device was used to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Additional information: g3, h6 correction: d1, d4(model number and catalog number), removed lot number, udi and pma / 510(k) # d10 concomitant product: unknown trocar, unknown trocar device (lot#unknown); unknown trocar, unknown trocar device (lot#unknown); u nknown trocar, unknown trocar device (lot#unknown) reportability decision has been downgraded from malfunction - reportable to not a complaint medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, intra-operatively of a laparoscopic gastric bypass, three trocars have failed to filter co2.The seals were damaged and disengaged.The devices leak air or gas.Another device was used to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Additional information: b5, d1, d4(expiration date, lot number and udi), pma / 510(k) #, g3, h4, updated rfr, fdd, fdp, ime and imf the report was initially submitted as reportable on 2024-01-29.However, it was further determined that the event is not reportable based on available information at that time and a correction supplemental report was submitted on 2024-02-05 to cancel the original report.On 2024-03-25, new information was received and after reassessment, this event is now deemed reportable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, intra-operatively of a laparoscopic gastric bypass, when inserting the trocars through the abdominal wall, the seals of three trocars were broken.Carbon dioxide (co2) leaked.All three trocars were replaced.There was no patient injury.
Additional Manufacturer Narrative
Additional information: g3 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18604029
• Report Number: 9612501-2024-00250
• Device Sequence Number: 9016909
• Product Code: GCJ
• UDI-Device Identifier: 30884521215423
• UDI-Public: 30884521215423
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K112349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/02/2024

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 Model Number: UNKNOWN TROCAR DEVICE
• Device Catalogue Number: UNKNOWN TROCAR DEVICE
• Device Lot Number: J3D0584Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2024
• Supplement Date Received by Manufacturer: 01/10/2024; 03/25/2024; 04/19/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 02/05/2024; 04/08/2024; 05/02/2024
• Date Device Manufactured: 04/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE NOTE ON H10.; SEE H10.
• Patient Sex: Female