MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO GIA; STAPLE, IMPLANTABLE

Model Number EGIA60AMT

Device Problems Difficult to Insert (1316); Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2023

Event Type  malfunction  

Manufacturer Narrative

D10 concomitant product: sigpshell - sig power sigpshell control shell, lot# n3b0647y sigphandle - sig power sigphandle handle, serial# (b)(6) sigadaptstnd - sig power sigadaptstnd linear adapter, serial# (b)(6) egia60amt - egia60amt egia 60 artic med thick sulu, lot# p2h0479 onb12shf - onb12shf versaone opt 12 sht trocar, lot# unk 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, during a laparoscopic rectal resection, in attempting  to insert the device to the trocar ,the closure of the jaws was insufficient.There was difficulty inserting into trocar unless with manual closed.The same was issue happened on the second reload.Afterwards, the closure of the attached reload was not done properly as the closure was added manually and inserted into the trocar.Postoperatively, the first reload that had not been used was reconnected, and when performed empty firing outside the body, the firing could be done without any problems.To complete the case another reload of the same size was used.There was no patient injury.

Manufacturer Narrative

Additional information: h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the reload had all full complement of staples, the jaw of the reload was open.Functionally, the reload was loaded into a representative instrument without any media in the jaws and fully clamped.Visual inspection of the reload after being fully clamped revealed a gap (between the anvil and cartridge face) at the distal end of the jaws.The jaws are aligned.Manual manipulation of the reload was required to insert the reload into a representative 12mm trocar.Media was placed in the jaws of the reload and the reload was fired.Acceptable knife cut and staple formation were confirmed through visual inspection.No abnormalities were found with the intended function of the reload (stapling and cutting).It was reported that the jaws of the reload did not close completely and difficulty inserting into trocar.The reported issues were confirmed.The most likely cause could not be established from the information available.Internal process improvements have been initiated to mitigate this issue.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Additionally, the investigation detected an unreported condition of egia sulu/reload clamped with shipping wedge attached that has no relationship to the reported condition.Visual inspection noted the shipping wedge was damaged.One part of the shipping wedge was stuck in the proximal end of the knife channel.The product analysis noted evidence that the device was not used as intended.This issue may occur if the shipping wedge pull tab is pulled in a lateral fashion towards the distal end of the sulu (single use loading unit) channel rather than away from the channel, or if the loading unit is clamped prior to removal of the yellow shipping wedge.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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: ENDO GIA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 17233943
• MDR Text Key: 318240504
• Report Number: 2647580-2023-02831
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884523003215
• UDI-Public: 10884523003215
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EGIA60AMT
• Device Catalogue Number: EGIA60AMT
• Device Lot Number: P2H0479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1