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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION LOOK PLAIN GUT 19MM REV CUTTING NEEDLE/SUTURE

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SURGICAL SPECIALTIES CORPORATION LOOK PLAIN GUT 19MM REV CUTTING NEEDLE/SUTURE Back to Search Results
Model Number 554B
Device Problem Break (1069)
Patient Problems Pain (1994); Swelling (2091)
Event Date 04/27/2017
Event Type  Injury  
Manufacturer Narrative
-method: the actual device was discarded. Sterile devices from the same lot were returned for testing and visual examination. -results/conclusions: relevant portions of the device history record were reviewed. The product from this finished good lot and all of the component lots met current usp and surgical specialties (b)(4) inc. Requirements throughout the incoming, manufacturing and the final inspection processes. The returned sterile samples from the same finished good lot were ductility tested and visually reviewed. All devices met the current requirements for this size/type needle/suture device. -without reviewing the actual device to determine tool placement, 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 with certainty.
 
Event Description
While attempting to place a dental implant in site #19 under iv sedation, the patient had a challenging airway. To correct the situation, the surgeon attempted to place a tongue traction suture to improve the airway. The needle fractured and was retained in the tongue. After unsuccessfully trying to retrieve it in the office, the patient was taken to hospital or, placed under general anesthesia via a nasal endotracheal tube. Once patient was asleep, paralyzed and airway under control, the needle segment was located and removed by enlarging previous incision. The needle was removed without further incident or injury to the patient. The patient will be re-evaluated when sutures are removed. Adverse sequelae reported:pain, swelling, decreased function of the tongue and delay in initial treatment. The incision may leave a possible scar and may decrease sensation in the area distal from to the incision that was required to remove the fragment.
 
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Brand NameLOOK
Type of DevicePLAIN GUT 19MM REV CUTTING NEEDLE/SUTURE
Manufacturer (Section D)
SURGICAL SPECIALTIES CORPORATION
corredor tijuana-rosarito 2000
24702-b, ejido francisco villa
tijuana 22235
MX 22235
Manufacturer (Section G)
SURGICAL SPECIALTIES CORPORATION
corredor tijuana-rosarito 2000 #24702b
ejido francisco villa
tijuana 22235
MX 22235
Manufacturer Contact
kelly knappenberger
1100 berkshire blvd.
ste 308
reading, PA 19608
MDR Report Key7004407
MDR Text Key91152096
Report Number3010692967-2017-00013
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K896554
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 05/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/16/2021
Device Model Number554B
Device Catalogue Number554B
Device Lot NumberAAAR758
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date04/27/2017
Device Age3 MO
Event Location Examination Room
Date Manufacturer Received05/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/16/2017
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: 11/06/2017 Patient Sequence Number: 1
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