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

Model Number	RNONB8STF
Medical Device Problem Codes	Difficult to Insert (1316); Product Quality Problem (1506)
Health Effect - Clinical Codes	Unspecified Infection (1930); Laceration(s) (1946)
Date of Event	01/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant product: ronb11stf postion v2 bldles opt 11m std (lot#: unknown).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, during a laparoscopic prosthetic device extraction, the standard trocar appeared to be too short for the patient.Switching instruments was very difficult, and the loss of positioning of the trocars through the wall was recurrent and risky.This is due to the fact that the patient had a high body mass index (bmi), a pneumoperitoneum, and trendelenburg limitations.The patient also had a very thick abdominal wall with a lot of fat layers inside the abdominal wall.The surgeon converted to open surgery for patient safety and due to the delay generated by the limitations of the trocars, in which the surgical time was extended by 30 minutes or more.An incision of more than 1 inch was made in the pubic area to access the target anatomy.The patient had 5 more days post-op surgery and had an infection resulting from the laparotomy.Moreover, the patient extended hospitalization for 7 days more, and an additional operation will be performed to correct the issue. .
Additional Manufacturer Narrative
Correction: notified date additional information: b5, 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.
Event or Problem Description
According to the reporter, during a laparoscopic prosthetic device extraction, the standard trocar appeared to be too short for the patient.Switching instruments was very difficult, and the loss of positioning of the trocars through the wall was recurrent and risky.This is due to the fact that the patient had a high body mass index (bmi), a pneumoperitoneum, and trendelenburg limitations.The patient also had a very thick abdominal wall with a lot of fat layers inside the abdominal wall.The surgeon converted to open surgery for patient safety and due to the delay generated by the limitations of the trocars, in which the surgical time was extended by 30 minutes or more.An incision of more than one inch was made in the pubic area to access the target anatomy.The patient had five more days post-op surgery and had an infection resulting from the laparotomy.Moreover, the patient extended hospitalization for seven days more, and an additional operation will be performed to correct the issue.It was noted that the patient was hospitalized for an abscess on the scar, infection and lack of healing of the bladder.
Event or Problem Description
According to the reporter, during a laparoscopic trans obturator tape removal (tot), the standard trocar appeared to be too short for the patient.Switching instruments was very difficult, and the loss of positioning of the trocars through the wall was recurrent and risky.This is due to the fact that the patient had a high body mass index (bmi), a pneumoperitoneum, and trendelenburg limitations.The patient also had a very thick abdominal wall with a lot of fat layers inside the abdominal wall.The surgeon converted to open surgery for patient safety and due to the delay generated by the limitations of the trocars, in which the surgical time was extended by 30 minutes or more.An incision of more than 1 inch was made in the pubic area to access the target anatomy.The patient had 5 more days post-op surgery and had an infection resulting from the laparotomy.Moreover, the patient extended hospitalization for 7 days more, and an additional operation will be performed to correct the issue.It was noted that the patient was hospitalized for an abscess on the scar, infection and lack of healing of the bladder due to reopening of the bladder 3 weeks after the hugo surgery.
Additional Manufacturer Narrative
Additional information: b5, 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: 18809031
• Report Number: 9612501-2024-00611
• Device Sequence Number: 17969675
• Product Code: GCJ
• UDI-Device Identifier: 10884521717640
• UDI-Public: 10884521717640
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K162584
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/03/2024

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: RNONB8STF
• Device Catalogue Number: RNONB8STF
• 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: 01/23/2024
• Supplement Date Received by Manufacturer: 02/26/2024; 04/17/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 03/22/2024; 05/03/2024
• 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: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Sex: Female
• Patient Weight: 130 KG