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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO GIA ULTRA; STAPLE, IMPLANTABLE
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US SURGICAL PUERTO RICO ENDO GIA ULTRA; STAPLE, IMPLANTABLE Back to Search Results
Model Number EGIAUSTND
Device Problems Break (1069); Device Slipped (1584)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/17/2024
Event Type  malfunction  
Event Description
According to the reporter, during a laparoscopic thoracoscopy partial pulmonary resection procedure, at the time of pulmonary parenchyma dissection, the gears of the handle went idle while attempting to fire the 5th reload.Therefore, stapling could not be performed.A new reload and a handle were used to resolve the issue.There was no patient injury.
 
Manufacturer Narrative
D10 concomitant product: sigtrsb60axt, sigtrsb60axt 60mm xtr thk reinforced rel (lot#n2j0596y) 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 thoracoscopy partial pulmonary resection procedure, at the time of pulmonary parenchyma dissection, the gears of the handle went idle while attempting to fire the 5th reload.Therefore, stapling could not be performed.A new reload and a handle were used to resolve the issue.There was no patient injury.Medtronic's evaluation of the device found that the visual inspection of internal components revealed sheared teeth on the firing rack which is indicative of being applied to tissue that is beyond the recommended thickness range.
 
Manufacturer Narrative
Additional information: b5, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the firing knobs were fully retracted.The articulation knob was in neutral position.Internal components revealed sheared teeth on the firing rack.The issue was resolved by using new reload and handle.It was reported that the gears of the handle went idle while attempting to fire.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: failure to completely fire the reload will result in an incomplete cut and/or incomplete staple formation, which may result in poor hemostasis and/or leakage.Always inspect the tissue thickness and select an appropriate staple size prior to application of the endo gia¿ ultra universal short, endo gia¿ ultra universal or endo gia¿ ultra universal xl stapler.Overly thick or thin tissue may result in unacceptable staple formation.When positioning the stapler on the application site, ensure that no obstructions, such as clips, are incorporated into the instrument jaws.Firing over an obstruction may result in incomplete cutting action and/or improperly formed staples.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.
 
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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 Key18705943
MDR Text Key336064968
Report Number2647580-2024-00772
Device Sequence Number1
Product Code GDW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K111825
Number of Events Reported1
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 02/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEGIAUSTND
Device Catalogue NumberEGIAUSTND
Device Lot NumberP3B0020
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2024
Is the Reporter a Health Professional? No
Date Manufacturer Received01/24/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
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