MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU; STAPLE, IMPLANTABLE

Model Number UNKNOWN ENDO GIA SULU

Device Problems Entrapment of Device (1212); Retraction Problem (1536); Misfire (2532); Failure to Form Staple (2579)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 01/04/2023

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: egiaustnd endogia ultra univ std stap (lot#: p2f0013).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 laparoscopic sleeve gastrectomy, when stapling the stomach, the physician could not staple until the end of the reload, it was too difficult.The jaws were locked on tissue.The physician had to use excessive force to retract the black knob and remove the device.After the physician managed to open the jaws, the tissue had been a little bit damaged.Some staples have not been formed properly or at all.There was also an incomplete staple line proximally or centrally.The physician decided to place the new stapler a little bit higher to staple a little bit above this damaged tissue part.This tissue part had been removed.A new handle and reload were used to complete the case.

• Brand Name: UNKNOWN ENDO GIA SULU
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 16268460
• MDR Text Key: 308419797
• Report Number: 1219930-2023-00359
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN ENDO GIA SULU
• Device Catalogue Number: UNKNOWN ENDO GIA SULU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2023
• 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
• Patient Outcome(s): Required Intervention