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

Model Number A127

Device Problem Pressure Problem (3012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/17/2018

Event Type  malfunction  

Event Description

It was reported that during surgery, the water pressure of the pump rise rapidly and the pump turned quickly, so the water was lowered to 5, but the pump constantly turned quickly and interrupted the op.Obstruction of vision.No patient injury reported.

Manufacturer Narrative

An evaluation was performed by the supplier and could not confirm the customer complaint for the water pressure of the pump raised rapidly and the pump turned quickly.A visual inspection was performed and showed the pump in good general condition.Functional inspection showed the return device passed all criteria.This included a flow test, pressure test, and an rpm test with a result of pass.All functional testing did not identify any functional abnormalities.No errors were triggered during any of the testing.No manufacturing related defects were observed.

• 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 west william cannon drive; austin, TX 78735
• MDR Report Key: 7553443
• MDR Text Key: 109689030
• Report Number: 3003604053-2018-00086
• Device Sequence Number: 1
• Product Code: FEQ
• UDI-Device Identifier: 04056702003715
• UDI-Public: (01)04056702003715
• 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,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: A127
• Device Catalogue Number: 72204968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2018
• 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: Reuse
• Patient Sequence Number: 1