MAUDE Adverse Event Report: RICHARD WOLF GERMANY (RWGMBH) TEM INSUFFLATOR

Model Number	2232641
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/11/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Facility reported that during a procedure, system would not inflate enough to fill patients' belly.Doctor opened up patients' abdomen in order to complete the procedure.Manufacture date - 18mar2016.Purchase date - (b)(6) 2016.Service dates - n/a.No similar events resulting in an mdr has occurred on this device type in the last three years.Facility indicated instruments would be returned for evaluation, not received as of (b)(6) 2017.When instruments are received, they will be sent to manufacturer for evaluation.Facility contacted twice, via email, in order to gather missing/additional information on this event, no response as of 11sep2017.Two instruments work together as one system, a mdr submitted for each device: 1) tem pump (id #2232.644) - mdr1418479-2017-00020.2) insufflator (id #2232641) - mdr1418479-2017-00021.Rwmic considers this matter closed.However, in the event rwmic receives additional information, follow-up report will be submitted to fda.
Event or Problem Description
Follow up #2.Follow up #1 contained in correct device name.Update following: medical device name, importer information.
Event or Problem Description
Follow up report #1.Richard wolf medical instruments corporation (rwmic) received device on 19sep2017.Device sent to (b)(4) manufacturer for investigation, no investigation results received as of 02oct2017.Rwmic received additional information from facility on 15sep2017.The following boxes have been updated: patient information, date/description of this report, suspect device (not changed, system required due to missing data report), initial reporter information, report type / date sent.
Additional Manufacturer Narrative
Follow up #3, the following was updated/completed: product problem, suspect device, importer (device), corrected/additional data.Richard wolf medical instruments corporation (rwmic) received investigation results from manufacturer on 10oct2017 and added new information to this follow up report.Manufacturer found no issues with device during electrical testing.Insufflator also tested with a pump and no issues were found.Rmic considers this matter closed.However, in the event rwmic receives any additional information a follow report will be submitted to fda.
Event or Problem Description
Follow up #3 - manufacturers investigation results.

• Brand Name: TEM INSUFFLATOR
• Common Device Name: TEM INSUFFLATOR
• Manufacturer (Section D): RICHARD WOLF GERMANY (RWGMBH); registration number 9611102; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• MDR Report Key: 6855240
• Report Number: 1418479-2017-00021
• Device Sequence Number: 16308457
• Product Code: HIF
• UDI-Device Identifier: 04055207056523
• UDI-Public: 04055207056523
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/15/2017
• Report Date (Section F): 10/17/2017

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
• Operator of Device: Physician
• Device Model Number: 2232641
• Device Catalogue Number: 2232.641
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/14/2017
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2017
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 09/11/2017
• Supplement Report FDA Received Date: 10/02/2017; 10/02/2017; 10/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TEM PUMP
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Weight: 93
• Date Report Sent to FDA: 10/17/2017