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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHROCARE CORP. FIRSTPASS SUTURE PASSER
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ARTHROCARE CORP. FIRSTPASS SUTURE PASSER Back to Search Results
Catalog Number 22-4035
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/15/2019
Event Type  malfunction  
Manufacturer Narrative
Foreign zip code: (b)(6).
 
Event Description
It was reported that during a procedure the device was broken.The pieces were removed, and no delays or injuries were reported, a back-up device was available.
 
Manufacturer Narrative
Actual completed date: (b)(6) 2019 sign-off comment the returned instrument, intended for use in treatment, was returned as an mdr for evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection under magnification shows a first pass suture passer which was returned with an detached top jaw.During the functional evaluation the ratchet release and the lever were tested without issue.Further functional test cannot be verified due to the missing component the complaint was verified and the root cause could not be properly determined.However likely cause could be (1) mechanical component failure (2) excessive force used (3) tissue thickness.
 
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Brand Name
FIRSTPASS SUTURE PASSER
Type of Device
PASSER
Manufacturer (Section D)
ARTHROCARE CORP.
7000 w. william cannon
austin TX 78735
MDR Report Key8405233
MDR Text Key138656519
Report Number3006524618-2019-00134
Device Sequence Number1
Product Code HWQ
UDI-Device Identifier00817470000160
UDI-Public00817470000160
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number22-4035
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2019
Date Manufacturer Received04/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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