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

Model Number	3948L
Medical Device Problem Codes	Product Quality Problem (1506); Failure to Fire (2610)
Health Effect - Clinical Codes	Tissue Damage (2104); No Code Available (3191)
Date of Event	03/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during colectomy, the reload was seen to be curved that made the knife unable to slide and blocked.The procedure was converted to open colectomy.
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 colectomy, the reload was seen to be curved that made the knife unable to slide and blocked.The procedure was converted to open colectomy.Another reload was used with the same handle to complete the case.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted there were cracks on the surface of the loading unit and on both sides of the sulu near the knife blade.It was reported that the device did not fire and the physical appearance of the product was different than expected.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur if a knife or a sharp object is used to separate the bottom plate from the cartridge.The manufacturing records for each device are also thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: serial numbers on the instrument halves must match for proper performance.Use of mixed parts may compromise patient safety.If the tissue to be stapled does not completely fill the device, the surgeon should consider removing any staples that are not discharged into tissue.Always include the combined thickness of the tissue and of any staple line reinforcement material in use when choosing the proper staple cartridge.The ilatm reusable staplers must be carefully inspected prior to and after each use, as any damage may affect the safe operation of the device.Failure to lubricate the device prior to sterilization may cause malfunctions such as jamming, difficult operation, or unacceptable staple formation.The ilatm reusable staplers and loading units should not be used to staple liver, spleen and other tissue with sinus beds whose compressibility is such that closure of the instrument may be destructive.The ilatm reusable staplers and loading units should not be used on tissue that will compress to less than 1.5 mm or 2.0 mm or that will not comfortably compress to 1.5 mm or 2.0 mm.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.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: ILA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 9927095
• Report Number: 2647580-2020-01232
• Device Sequence Number: 11454163
• Product Code: GDW
• UDI-Device Identifier: 10884521063150
• UDI-Public: 10884521063150
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K885047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2020

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: 08/31/2024
• Device Model Number: 3948L
• Device Catalogue Number: 3948L
• Device Lot Number: P9J1243Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 06/17/2020; 07/23/2020
• Initial Report FDA Received Date: 04/05/2020
• Supplement Report FDA Received Date: 06/18/2020; 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention