• 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. BLADE,STAINLESS-STEEL,15,STERILE,DISP

  • 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. BLADE,STAINLESS-STEEL,15,STERILE,DISP Back to Search Results
Catalog Number MDS15115
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2021
Event Type  malfunction  
Manufacturer Narrative
It was reported, surgical blade #15 tip broke off during surgery. X-ray completed. No retained piece(s) located on x-ray. Med watch (b)(4), received by the fda. It was reported, "on (b)(6) 2021, during an anastomosis revision, a surgical blade broke off. #15 tip blade broke off during surgery. X-ray completed-none retained. No patient harm. " initial reporter further states that the sample had "all been thrown out. " due to a sample not being available a root cause will be difficult if not impossible to determine. Due diligence has been completed. No additional details are available related to the customer reported issue. Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer. Due to the reported incident, medical intervention and in an abundance of caution, this medwatch is being filed. If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
 
Event Description
It was reported surgical blade #15, tip broke off during surgery. X-ray completed. No retained piece(s) located on x-ray.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceBLADE,STAINLESS-STEEL,15,STERILE,DISP
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield IL 60093
Manufacturer Contact
teresa maynard
three lakes drive
northfield, IL 60093
2249311514
MDR Report Key11825978
MDR Text Key254169792
Report Number1417592-2021-00088
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMDS15115
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/14/2021 Patient Sequence Number: 1
-
-