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

MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION LOOK LOOK C17 6-0 BLACK MONO NYL 18"/45CM

  • 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
 

SURGICAL SPECIALTIES CORPORATION LOOK LOOK C17 6-0 BLACK MONO NYL 18"/45CM Back to Search Results
Model Number 916B
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/02/2017
Event Type  malfunction  
Manufacturer Narrative
-method: the actual product involved with the incident was discarded. Sterile samples from the same finished good lot were returned for evaluation. -results/conclusions: all samples were visually reviewed and ductility/bend tested and met current requirements for this size/type needle/suture device. Relevant portions of the device history record were reviewed. The product from this finished good lot and all of the component lots met current (b)(4). Requirements throughout the incoming, manufacturing and the final inspection processes. No inventory is available for the finished good lot reported. -without receiving the actual broken device to review/test, receiving detailed information regarding the pre-operative preparation of the device or the surgeon's technique, a definitive root cause for the needle breaking during use cannot be determined at this time.
 
Event Description
It was reported by the end user that the needle broke while suturing a chin laceration. An x-ray was required to locate the needle segment retained in the wound. The piece was removed without injury or further incident.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLOOK
Type of DeviceLOOK C17 6-0 BLACK MONO NYL 18"/45CM
Manufacturer (Section D)
SURGICAL SPECIALTIES CORPORATION
corredor tijuana-rosarito 2000
24702-b, ejido francisco villa
tijuana 22235
MX 22235
Manufacturer Contact
kelly knappenberger
1100 berkshire blvd.
ste 308
reading, PA 19608
MDR Report Key6990909
MDR Text Key91923012
Report Number3010692967-2017-00010
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K903029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 02/02/2017,02/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/09/2021
Device Model Number916B
Device Catalogue Number916B
Device Lot NumberMBGY030
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/31/2017
Device Age8 MO
Event Location Hospital
Date Report to Manufacturer02/02/2017
Date Manufacturer Received02/02/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/09/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/31/2017 Patient Sequence Number: 1
-
-