MAUDE Adverse Event Report: RICHARD WOLF GMBH TEM PUMP

Model Number	2232.644
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility was contacted and all available information was provided.The device was not available to be returned for evaluation,on-site evaluation by the sales representative determined that the issue was caused by a defective outlet.(b)(4).Caution! the tem pump must be enabled to properly perform the tem procedures! it is possible to engage the laparoscopic insufflator function when the tem configuration is desired.When performing tem applications be sure that the pump indicator is illuminated.If the pump is not enabled, the insufflator will cycle between its insufflation and measurement periods.This can be detected by a visual pulsing of the gas flow indicator and an audible pause in the insufflation mode.If this situation is detected, change the mode as written in section 4.8.2.Check all connections and assure that the pump is enabled.Power failure should the power supply fail: ·selected modes are stored for approx.20 s when the power supply is restored: ·power failure for less than 20 seconds: the application is continued with the settings previously selected.·if the power failure is longer than 20 seconds: the laparo co2 pneu runs through the automatic function test.(b)(4) considers this case closed.Should additional information become available a follow up report will be submitted.
Event or Problem Description
On (b)(6) 2018, (b)(4) received medwatch report # (b)(4).The following was reported: "patient scheduled for a transanal endoscopic microsurgical excision of the rectal tumor using the (b)(4) tem machine.The patient was intubated and a proctosigmoidoscopy was performed by the surgeon and then the patient was positioned and prepped for surgery.When it came time to start the machine only the top unit was lighting up and working (insufflator).The bottom unit did not turn on.Other staff came into the room to troubleshooting the problem with no luck getting the bottom unit to turn on.The (b)(4) rep, and team leader was called to help troubleshooting.At this time the surgeon wanted to abort the case." the device was not returned for evaluation.The sales representative went to the user facility to investigate the reported issue and found that the cause of the problem was a defective outlet.The unit was plugged into a different outlet and began working.

• Brand Name: TEM PUMP
• Common Device Name: TEM PUMP
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 8407944
• Report Number: 1418479-2018-00025
• Device Sequence Number: 13906032
• Product Code: HIF
• UDI-Device Identifier: 04055207056462
• UDI-Public: 04055207056462
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K000180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: company representative,health
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/24/2018
• Report Date (Section F): 03/11/2019

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
• Operator of Device: Health Professional
• Device Model Number: 2232.644
• Device Catalogue Number: 2232.644
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/24/2018
• Device Age: 10 YR
• Event Location: Other
• Date Report to Manufacturer: 03/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Date Report Sent to FDA: 03/11/2019