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

MAUDE Adverse Event Report: ARTHROCARE CORP. DISP FIRSTPASS STR PASSR SELF PASSER

  • 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
 

ARTHROCARE CORP. DISP FIRSTPASS STR PASSR SELF PASSER Back to Search Results
Catalog Number 22-4038
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/06/2017
Event Type  malfunction  
Manufacturer Narrative
Event description was updated.
 
Event Description
It was reported that when the firstpass suture passer was removed from the patient, there was no self capture component present. The procedure was successfully completed using a back-up device. However, the incident resulted in a surgical delay greater than 30 minutes in order to perform an arthroscopic assessment of joint and fluoroscopy of patient to ensure the missing self capture component was not present in surgical site. No patient injury or other complications were reported.
 
Manufacturer Narrative
A relationship between the device and reported incident was established based on our visual observations. From the information provided, the fpst came out the patient and there was not self capture. Visual inspection shows the device was received with no suture trap. A needle was found inside the device and no other visual discrepancies were observed. Root cause for missing self capture is due to incorrect assembly or missing during the process. Changes have been implemented to reduce/ eliminate the failure. The instruction for use (ifu) were reviewed and were found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality. There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
 
Event Description
It was reported that the first pass suture came out the patient and there was not self capture. Procedure delay was greater than 30 minutes but less than an hour, no patient injuries were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDISP FIRSTPASS STR PASSR SELF
Type of DevicePASSER
Manufacturer (Section D)
ARTHROCARE CORP.
7000 w. william cannon
austin TX 78735
Manufacturer (Section G)
ARTHROCARE CORP.
7000 w. william cannon
austin TX 78735
Manufacturer Contact
jim gonzales
7000 w. william cannon drive
austin, TX 78735
MDR Report Key7039305
MDR Text Key249017561
Report Number3006524618-2017-00370
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Catalogue Number22-4038
Device Lot Number1138385
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/29/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-