• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. STAPLER,SKIN,35 WIDE,W/COUNTER,STERILE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDLINE INDUSTRIES INC. STAPLER,SKIN,35 WIDE,W/COUNTER,STERILE Back to Search Results
Catalog Number STAPLER35W
Device Problem Separation Failure (2547)
Patient Problem No Code Available (3191)
Event Date 10/15/2019
Event Type  Malfunction  
Manufacturer Narrative

It was reported that while using the skin stapler for wound closure, the device was found to be difficult to disengage after stapling. According to the reporting facility, the staples inserted with the skin stapler were "misplaced. " these staples were removed and the patient's wound was closed using sutures instead of staples. The manufacturer was provided with three (3) different lot numbers of skin staplers at the reporting facility (lot 86418080238, lot 86418110231, and lot 86418110232) but the lot number of the skin stapler involved in the reported incident is unknown. Skin staplers from lot 86418110231 and lot 86418110232 were returned to the manufacturer. Visual inspection identified no issues at the time of evaluation. Functional analysis was performed by using the skin stapler to staple sections of a skin mat. The skin staplers were found to stick once engaged and when disengaged, it was found to pull on the staple. A root cause was unable to be determined at this time. Due to the reported need for medical intervention to remove the inserted staples and perform wound close via sutures, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.

 
Event Description

It was reported that the skin stapler was difficult to disengage after stapling.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceSTAPLER,SKIN,35 WIDE,W/COUNTER,STERILE
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield IL 60093 2753
Manufacturer Contact
nigel vilches
three lakes drive
northfield, IL 60093-2753
2249311458
MDR Report Key9286435
MDR Text Key190762667
Report Number1417592-2019-00185
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 11/06/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/06/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberSTAPLER35W
Device LOT NumberSEE H10
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/29/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2019
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 11/06/2019 Patient Sequence Number: 1
-
-