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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT SINGLE FUNCTION HNDPC ABC ELEC; APPARATUS, ELECTROSURGICAL

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CONSOLIDATED MEDICAL EQUIPMENT SINGLE FUNCTION HNDPC ABC ELEC; APPARATUS, ELECTROSURGICAL Back to Search Results
Catalog Number 130344
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The reported device is expected to be returned for evaluation.A supplemental and final report will be filed upon the completion of the product evaluation and the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.
 
Event Description
During incoming inspection, the distributor rejected this device, 130344, for an insufficient heatseal.There was no contact with the patient as this was found during incoming inspection.Due to the potential severity of a breach in sterility, this complaint meets the criteria for a reportable event.This will be reported as a malfunction with potential for injury upon reoccurrence.
 
Manufacturer Narrative
Two 130344 were received in unopened original packaging, the reported catalog and lot numbers were verified.Visual inspection found no obvious signs of abnormalities or defects.The device was dye leak tested.Testing finding there was not a breach within the sterile barrier.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 5 complaints, regarding 75 devices, for this device family and failure mode.During this same time frame 200,250 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.0004.Per the instructions for use, the user is advised the following: contraindications: these devices should never be used when: -there is visible evidence of damage to the exterior of the device, such as ducts, punctures, nicks abrasions, unusual lumps or significant discoloration.Inspection: these devices should be inspected before use.Visually examine the device for obvious physical damage and do not use if damage is found: -cracked, broken or otherwise distorted plastic parts; -broken or significantly bent handle, shaft or connector contacts.This issue will continue to be monitored through the complaint system to assure patient safety.
 
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Brand Name
SINGLE FUNCTION HNDPC ABC ELEC
Type of Device
APPARATUS, ELECTROSURGICAL
Manufacturer (Section D)
CONSOLIDATED MEDICAL EQUIPMENT
alejandro dumas ave, 11321
complejo industrial chihuahua
chihuahua, 31136
MX  31136
MDR Report Key8941290
MDR Text Key206367404
Report Number3007305485-2019-00308
Device Sequence Number1
Product Code HAM
Combination Product (y/n)N
PMA/PMN Number
K871435
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 10/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/15/2023
Device Catalogue Number130344
Device Lot Number201807164
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/04/2019
Initial Date Manufacturer Received 08/06/2019
Initial Date FDA Received08/28/2019
Supplement Dates Manufacturer Received10/09/2019
Supplement Dates FDA Received10/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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