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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PUMP A127 GOFLO PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE

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SMITH & NEPHEW, INC. PUMP A127 GOFLO PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE Back to Search Results
Catalog Number 72204968
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/20/2018
Event Type  malfunction  
Event Description
It was reported that during a knee arthroscopy, the goflo pump water pump gave error message 06 "call service" and it did not work during the surgery. There was no backup available so procedure was done by gravity. No procedure delay or patient injuries were reported.
 
Manufacturer Narrative
An evaluation was performed by the supplier and could confirm the customer complaint for the goflo pump water pump gave error message 06. A visual inspection was performed and showed no damage. The roller wheel and individual rollers were all inspected and were found to be in great condition. Functional inspection was performed and the pump passed initial self-test successfully. During functional testing the unit was started but the motor would not function shortly after an error 06 (motor error) was triggered. The results of investigation indicated the pump failed due to it is out of calibration. The calibration data itself was verified and found to be the same as when it left the production for this reason it seems to be most likely that the characteristic of the motor has slightly changed causing the reported error code. After motor calibration was performed the pump functioned normally without further errors. (b)(6).
 
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Brand NamePUMP A127 GOFLO
Type of DevicePUMP, AIR, NON-MANUAL, FOR ENDOSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
Manufacturer (Section G)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
Manufacturer Contact
jim gonzales
7000 w. william cannon drive
austin, TX 78735
MDR Report Key7422095
MDR Text Key105403222
Report Number3003604053-2018-00056
Device Sequence Number1
Product Code FEQ
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,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72204968
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/27/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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