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

Model Number	A127
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/17/2018
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 7553443
• Report Number: 3003604053-2018-00086
• Device Sequence Number: 19281249
• Product Code: FEQ
• UDI-Device Identifier: 04056702003715
• UDI-Public: (01)04056702003715
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2018

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1