MAUDE Adverse Event Report: RICHARD WOLF GMBH TEM PUMP

Model Number 2232.644

Device Problems Use of Device Problem (1670); Device Displays Incorrect Message (2591)

Patient Problem Bowel Perforation (2668)

Event Date 07/01/2014

Event Type  Injury  

Event Description

During a transanal endoscopic procedure the co2 ran out.Once co2 was replaced the value on the device did not change and/or reset.All tubing was disconnected and then reconnected and an error 11 appeared on the device.Tubing was replaced with new, device turned off/on and error 11 still displayed on device.Delay in procedure may have placed patient at risk.Doctor proceeded on and opened up abdomen and performed a different procedure.Sometime while patient was on table, bowel was perforated.

Manufacturer Narrative

An investigation was completed as the actual device was returned to the rwmic facility on (b)(4) 2014.Device history: sold on 01/12/2010, repaired 02/28/2011 and 06/2013.Unable to replicate issue.Device to be turned on and automatic function check performed prior to adding tubing to device.If tubing in device during automatic function check an error message occurs.Labeling was reviewed and found to be adequate, i.E.Intended use, indications and field of use, preparation and cautions.Error 11 is overpressure alarm, greater than 30 mm hg for more than 5 seconds.Richard wolf considers this matter closed.However, in the event we receive additional information, we will provide fda with follow-up information.

• Brand Name: TEM PUMP
• Type of Device: TEM PUMP
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strabe 32; GM
• MDR Report Key: 4036981
• MDR Text Key: 4879580
• Report Number: 1418479-2014-00042
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2014,07/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2232.644
• Device Catalogue Number: 2232.644
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/18/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/22/2014
• Distributor Facility Aware Date: 07/23/2014
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/22/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/22/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other