MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD APPOSE ULC; STAPLE, REMOVABLE (SKIN)

Model Number 8886803712

Device Problems Entrapment of Device (1212); Failure to Form Staple (2579); Failure to Fire (2610); Detachment of Device or Device Component (2907)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2024

Event Type  malfunction  

Manufacturer Narrative

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 a skin closure procedure, the device disintegrated into their individual parts during use, the individual staples did not close completely so there was no hold in the skin or the wound suture did not close.It was also reported that the stapling was not possible or the individual staples got caught in the device.

Event Description

According to the reporter, during a skin closure procedure, all six devices disintegrate into their individual parts during use, the individual staples do not close completely so that there was no hold in the skin or the wound suture did not close.It was also reported that the stapling was not possible or the individual staples get caught in the device.There was no patient injury.

Manufacturer Narrative

D10 concomitant product: 8886803712, 8886803712 appose ulc 35 wide skin stap (lot#unknown); 8886803712, 8886803712 appose ulc 35 wide skin stap (lot#unknown); 8886803712, 8886803712 appose ulc 35 wide skin stap (lot#unknown); 8886803712, 8886803712 appose ulc 35 wide skin stap (lot#unknown); 8886803712, 8886803712 appose ulc 35 wide skin stap (lot#unknown).H6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.Thirty nine representative samples were available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that there was a component that disengaged, the skin stapler instrument did not fire, there was a problem with staple formation and there was staple hang-up.The reported issues 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 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.

• Brand Name: APPOSE ULC
• Type of Device: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18988344
• MDR Text Key: 338730703
• Report Number: 9612501-2024-00852
• Device Sequence Number: 1
• Product Code: GDT
• UDI-Device Identifier: 10884521104372
• UDI-Public: 10884521104372
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K900486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8886803712
• Device Catalogue Number: 8886803712
• Device Lot Number: J3D2089LY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2023
• 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
• Treatment: PLEASE SEE NOTE ON H11