MAUDE Adverse Event Report: RICHARD WOLF GERMANY (RWGMBH) STRAIGHT TROCAR SLEEVE

Model Number	8919.333
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Richard wolf medical instruments cooperation (rwmic) was informed that during a procedure a black plastic foreign object found during procedure.Foreign object was easily retrieved, back up device was readily available for use and procedure completed as scheduled.No injury to patient or staff reported.Date rwmic receive device: 02mar2017.Date facility purchased device: 26jul2017.Service dates: n/a.Device approximately 7 months old.Facility has been contacted, via phone and email, in an effort to gather additional/missing for medwatch report.No response received as of 09oct2017.No similar complaints have been reported on this device type in the last three years.Device has not been returned.Once rwmic receives device, it will be sent to manufacturer for investigation.Rwmic considers this report closed.If rwmic receives additional information regarding this incident, a follow up report will be sent to the fda.
Additional Manufacturer Narrative
Follow up #2.The following sections updated/added: product problem, suspect device, importer (device), corrected data.Richard wolf medical instruments corporation (rwmic) received investigation results from manufacturer on 12dec2017.No issues were found with device when visually inspection by the manufacturer.Manufacturer indicated the foreign object did not come the suspect device.Facility was contacted several times, via fax and phone, in an effort gather additional/missing information.No response as of 04jan2018.Rwmic considers this matter closed.However, in the event rwmic receives any additional information a follow up report will be submitted to fda.
Event or Problem Description
Follow up #2.
Additional Manufacturer Narrative
Follow up # 1, the following was updated/ completed: patient information - patient identifier, age or date of birth, sex, weight.Product problem - date of event.Suspect device - brand name, common device name, device available for evaluation.Richard wolf medical instruments corporation (rwmic) received an email from user facility on 17 oct 2017 with additional information.In addition, device was returned to rwmic and sent to manufacture on 03 nov 2017.New information added to this follow up report.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 report #1.

• Brand Name: STRAIGHT TROCAR SLEEVE
• Common Device Name: TROCAR SLEEVE
• Manufacturer (Section D): RICHARD WOLF GERMANY (RWGMBH); registration number 9611102; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• MDR Report Key: 6932439
• Report Number: 1418479-2017-00027
• Device Sequence Number: 11101376
• Product Code: FBQ
• UDI-Device Identifier: 04055207021996
• UDI-Public: 04055207021996
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2017
• Report Date (Section F): 11/07/2017

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: 8919.333
• Device Catalogue Number: 8919.333
• Device Lot Number: 1333148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/18/2017
• Device Age: 7 MO
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 11/07/2017
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/09/2017
• Supplement Report FDA Received Date: 11/07/2017; 01/05/2018
• 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: 31 YR
• Patient Weight: 52
• Date Report Sent to FDA: 11/07/2017