MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PERI-STRIPS MESH, SURGICAL

Catalog Number PSDA60ECH

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Patient Involvement (2645)

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation. During visual inspection, both buttresses were observed to still be contained within the sheath with the paper backer still intact. The anvil side tissue buttress was partially displaced from under the sheath rails on the distal side of the sheath. The paper backer was removed from both the cart and anvil sides with no further disturbance to the tissue position, loaded onto a stapler, and fired with no adhesion issues. The reported condition was verified. The cause of the condition was due to user error. Per the labeling for peri-strips, it states, the paper backer to be removed prior to use. When loading the buttress onto the stapler, the customer likely grabbed both the tissue and tab of the paper backer and pulled the tissue out of the sheath. If this issue occurs, the customer may reposition the buttress once it¿s on the stapler, similar to what was done during sample evaluation, to ensure staple line coverage (step 18). Should additional relevant information become available, a supplemental report will be submitted.

Event Description

During device evaluation, it was found the user failed to follow instructions during use of the peri-strips. When loading the buttress onto the stapler, the customer likely grabbed both the tissue and tab of the paper backer and pulled the tissue out of the sheath. If this issue occurs, the customer may reposition the buttress once it's on the stapler, similar to what was done during sample evaluation, to ensure staple line coverage. The event occurred prior to patient use; therefore, there was no patient involvement. No additional information is available.

• Brand Name: PERI-STRIPS
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave. w; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 10524893
• MDR Text Key: 206730403
• Report Number: 1416980-2020-05642
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/11/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: PSDA60ECH
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial