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

Model Number	TA9035L
Medical Device Problem Codes	Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559)
Date of Event	07/14/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
According to the reporter, during an open restoration of intestinal continuity, when surgeon was making an anastomosis between the ileum and colon, the stapler was placed with a blue reload across the ileum and colon, the handle closed on the first squeeze, returned to the open position following the first full squeezed of the handle and then was closed the second time to complete the firing and the handle remained in the closed position. the surgeon transected across correct side stapler and bowel slipped out of jaws as there were no staples present at all. there was two inches extra of bowel that needed to be removed and then the surgeon had to redo the anastomosis with another stapler and loading unit. the length of the surgery time was extended by at least 45 minutes.Tissue damage and unanticipated tissue loss were noted. the surgeon was unsure whether the patient will have an extended hospital stay due to this issue.
Additional Manufacturer Narrative
D10 concomitant prod: ta9048s ta9048s ta 90-4.8 reloadable stapler p2d0160 correction: b5 additional info: d10, g1 (manufacturer name, mfr contact first name, last name, street 1, mfr city, region, postal code, email, phone number), g3, h6 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 or Problem Description
According to the reporter, during an open restoration of intestinal continuity, when surgeon was making an anastomosis between the ileum and colon, the stapler was placed with a blue reload across the ileum and colon, the handle closed on the first squeeze, returned to the open position following the first full squeezed of the handle and then was closed the 2nd time to complete the firing and the handle remained in the closed position. surgeon transected across correct side stapler and bowel slipped out of jaws as there were no staples present at all.  there was some blood loss and the surgeon stopped the bleeding.There were 2 inches extra of bowel that needed to be removed and then the surgeon had to redo the anastomosis with another stapler and loading unit. the length of the surgery time was extended by at least 45 minutes.Tissue damage and unanticipated tissue loss were noted. the surgeon was unsure whether the patient will have an extended hospital stay due to this issue.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.One representative sample and one photo were available for evaluation.The evaluation found no potentially contributing factors.It was reported that the staples did not deploy from the stapler after the handle was squeezed.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.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.
Event or Problem Description
According to the reporter, during an open restoration of intestinal continuity, when surgeon was making an anastomosis between the ileum and colon, the preloaded loading unit was not fired and then loading unit was replaced with blue reload.Then, the stapler was placed across the ileum and colon, the handle closed on the first squeeze, returned to the open position following the first full squeezed of the handle and then was closed the 2nd time to complete the firing and the handle remained in the closed position.  surgeon transected across correct side stapler and bowel slipped out of jaws as there were no staples present at all.  there was blood loss of approximately 300 cubic centimeter (cc) and the surgeon stopped the bleeding.There were 2 inches extra of bowel that needed to be removed and then the surgeon had to redo the anastomosis with another stapler and loading unit. the length of the surgery time was extended by at least 45 minutes.Tissue damage and unanticipated tissue loss were noted. the surgeon was unsure whether the patient will have an extended hospital stay due to this issue.

• Brand Name: TA
• Common Device Name: 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, CO 55112 ; 7635265677
• MDR Report Key: 15135110
• Report Number: 2647580-2022-02590
• Device Sequence Number: 5619266
• Product Code: GDW
• UDI-Device Identifier: 10884521043244
• UDI-Public: 10884521043244
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/28/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: TA9035L
• Device Catalogue Number: TA9035L
• Device Lot Number: P0F0573MY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 08/04/2022; 10/28/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 08/18/2022; 10/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Weight: 92 KG