MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGILON; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number 88861990-42J

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); Unintended Radiation Exposure (4565)

Event Date 06/09/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, on an open pancreatoduodenectomy, while puncturing and ligating vessel, when the surgeon picked up the needle and tried to pull it out to remove it from the thread, it was noticed that the tip of the needle had a missing of 2mm.Intra-operative x-ray and postoperative ct was done.

Manufacturer Narrative

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 Description

According to the reporter, on an open pancreatoduodenectomy, while puncturing and ligating vessel, when the surgeon picked up the needle and tried to pull it out to remove it from the thread, it was noticed that the tip of the needle had a missing of 2mm.Intra-operative x-ray and postoperative ct was done but the needled was not found.

Manufacturer Narrative

H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was returned for analysis.Visual inspection noted one suture and two needles.A needle was received attached to a suture.The remaining needle was detached and the tip of the needle was missing.Functional evaluation could not be performed on the product because sealed samples were not returned.A review of the device history record indicates the product was released meeting all medtronic quality release specifications at the time of manufacture.All reported conditions were confirmed.The most likely cause could not be established from the information available.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.

• Brand Name: SURGILON
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• MDR Report Key: 12105335
• MDR Text Key: 259588754
• Report Number: 9612501-2021-01095
• Device Sequence Number: 1
• Product Code: GAR
• UDI-Device Identifier: 20884521074825
• UDI-Public: 20884521074825
• Combination Product (y/n): N
• PMA/PMN Number: K981582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2021

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
• Device Operator: Health Professional
• Device Model Number: 88861990-42J
• Device Catalogue Number: 88861990-42J
• Device Lot Number: D0H2989Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Initial Date Manufacturer Received: 06/09/2021
• Initial Date FDA Received: 07/02/2021
• Supplement Dates Manufacturer Received: 06/22/2021; 09/28/2021
• Supplement Dates FDA Received: 07/16/2021; 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention