• 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. DISPOSABLE FIRSTPASS SUTURE PASSER, SELF

  • 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. DISPOSABLE FIRSTPASS SUTURE PASSER, SELF Back to Search Results
Model Number 22-4038
Device Problem Positioning Failure (1158)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/20/2020
Event Type  Injury  
Event Description
It was reported that during an arthroscopy the first-pass suture was not passing through the rotator cuff. The needle was bent. The procedure was completed using an smith & nephew accupass device. A delay of 10 minutes was reported. No patient injury or other complications were reported. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDISPOSABLE FIRSTPASS SUTURE PASSER, 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
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key10050159
MDR Text Key190757271
Report Number3006524618-2020-00253
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 06/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number22-4038
Device Lot Number2040498
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/17/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/12/2020 Patient Sequence Number: 1
-
-