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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION PERI-STRIPS MESH, SURGICAL Back to Search Results
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.
 
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Brand NamePERI-STRIPS
Type of DeviceMESH, 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 Key10524893
MDR Text Key206730403
Report Number1416980-2020-05642
Device Sequence Number1
Product Code FTM
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
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 Received09/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberPSDA60ECH
Device Lot NumberASKU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/26/2020
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

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