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

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).

• Brand Name: PUMP A127 GOFLO
• Type of Device: PUMP, 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 Key: 7422095
• MDR Text Key: 105403222
• Report Number: 3003604053-2018-00056
• Device Sequence Number: 1
• Product Code: FEQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72204968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/19/2018
• 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: N
• Patient Sequence Number: 1
• Patient Age: 58 YR