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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED, LLC ARC WRIST TOWER TRAY 1 OF 2 APPARATUS, TRACTION, NON-POWERED

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ACUMED, LLC ARC WRIST TOWER TRAY 1 OF 2 APPARATUS, TRACTION, NON-POWERED Back to Search Results
Model Number 10100001
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2022
Event Type  malfunction  
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for evaluation. Manufacturing and inspection records were reviewed, and no anomalies were found.
 
Event Description
During the pre-op phase of a wrist arthoscopy surgery, an "open box failure" was found and resulted in a 20 minute delay of the procedure. The procedure was completed and no alternate device was used. It was reported that there was no patient or user impact. Attempts to obtain further information regarding the "open box failure" have been made to no avail.
 
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Brand NameARC WRIST TOWER TRAY 1 OF 2
Type of DeviceAPPARATUS, TRACTION, NON-POWERED
Manufacturer (Section D)
ACUMED, LLC
5885 ne cornelius pass road
hillsboro OR 97124
Manufacturer (Section G)
ACUMED LLC
5885 ne cornelius pass road
hillsboro OR 97124
Manufacturer Contact
ellie wood
5885 ne cornelius pass road
hillsboro, OR 97124
5035209618
MDR Report Key14246038
MDR Text Key294666225
Report Number3025141-2022-00118
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10100001
Device Catalogue Number10100001
Device Lot Number523151
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received08/03/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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