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

Model Number EGIAUSTND

Device Problems Entrapment of Device (1212); Retraction Problem (1536)

Patient Problems Hemorrhage/Bleeding (1888); Tissue Breakdown (2681)

Event Date 01/30/2024

Event Type  Injury  

Manufacturer Narrative

D10 concomitant product: egia45ctavm egia45 curved vas med sulu (lot#: n2f0708y) 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 the single port thoracoscopic left upper lobectomy, when dealing with the left upper lobe artery, after the handle and staples were installed, it was fired normally.However, when the staple was withdrawn, the reset cap could only retract to 2/3, resulting in the reload being unable to be opened.After trying many operations, it still could not open the jaws.Finally, the vascular clip was used to block the artery at the proximal and distal ends of the reload, and then the suture was usedto manually suture the blood vessels.The reload was then taken out.The amount of blood loss during the operation was more than 500cc.And the patient had blood transfusion.The surgical time was extended for more than 30 minutes as a result.

Manufacturer Narrative

Additional information: d9, g3, h3, h6 correction: b5 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the instrument was received engaged with the subject reload.The instrument firing knobs were advanced to between the 45 mark and the 60 mark and the articulation lever was in neutral position.Functionally, the retract knobs were fully retracted and the subject reload jaws opened.The subject reload was unloaded from the instrument.The instrument was successfully loaded with a representative single use loading unit (sulu).The instrument successfully clamped, cycled fully, opened, and unloaded repeatedly without difficulty.It was reported that the instrument locked on tissue and was difficult to retract.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.The firing knobs were not fully retracted after firing the device.Please be sure to fully retract the instrument firing knobs to the home position to allow for release of the reload jaws.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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 Description

According to the reporter, during the single port thoracoscopic left upper lobectomy, when dealing with the left upper lobe artery, after the handle and staples were installed, it was fired normally.However, when the staple was withdrawn, the reset cap could only retract to 2/3, resulting in the reload being unable to be opened.After trying many operations, it still could not open the jaws.Finally, the vascular clip was used to block the artery at the proximal and distal ends of the reload, and then the suture was used to manually suture the blood vessels.The reload was then taken out.The amount of blood loss during the operation was more than 500cc.And the patient had blood transfusion.The surgical time was extended for more than 30 minutes as a result.

• Brand Name: ENDO GIA ULTRA
• 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: 18736008
• MDR Text Key: 335705331
• Report Number: 2647580-2024-00827
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EGIAUSTND
• Device Catalogue Number: EGIAUSTND
• Device Lot Number: P2D0294S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2024
• Date Device Manufactured: 04/12/2022
• 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
• Treatment: SEE NOTE ON H11
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 71 KG