MAUDE Adverse Event Report: RICHARD WOLF GMBH INSULATED SHEATH TUBE

Model Number	8393933
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rwmic considers this case open.The user facility and manufacturer will be contacted again in an effort to collect missing information.Device labeling was reviewed for patient and device codes: patient code: not applicable, no patient problem was reported.Ifu was reviewed the following warnings, cautions, and checks were found: warning! do not combine products incorrectly! injuries of the patient, user or others as well as damage to the product are possible.Caution! excessive force can lead to breakage of or damage to the products.Due to the small dimensions required, the products have only limited strength.Use these products only to grasp and ablate small, soft tissue portions or organs.For therapeutic applications we recommend having a backup instrument at hand.Make sure that no missing parts remain in the patient.Caution! be careful if products are damaged or incomplete! injuries of the patient, user and others are possible.Run through the checks before and after each use.Do not use the products if they are damaged, incomplete or have loose parts.Return damaged products together with any loose parts for repair.Do not attempt to do any repairs yourself.Check the instruments and accessories for the following: damage; surface changes (e.G.Corrosion); sharp edges not suitable for the application; loose or missing parts; rough surfaces.A follow up report will be submitted upon receipt of new or additional information.Rwmic considers this case open.
Event or Problem Description
On september 18 2018, the user facility reported the following to richard wolf medical instruments corporation (rwmic): "tip of insert broke off in patient." will the device be returned? yes.Was the device being used during a procedure when the issue occurred? yes.Specifically, was the device being used on a patient when the issue occurred? yes.Was there any injury or illness to patient or other personnel due to issue? no.Did the issue cause a delay in the procedure being performed that put the patient at risk? no.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.How was the patient anesthetized? unknown.Rwmic received and evaluated the device.The device was visually and functionally evaluated.The reported malfunction could not be verified during evaluation.Device was found to have no problem.No manufacturing defect was identified during the evaluation.The other components of the modular system, the grasping forcep insert and the pistol shaped handle, are considered suspect devices and a report will be submitted for each device.Grasping forcep insert - product number 8393.292 (mdr 1418479-2018-00032).Pistol shaped handle - product number 83930072 (mdr 1418479-2018-00033).Insulated sheath tube - product number 8393933.

• Brand Name: INSULATED SHEATH TUBE
• Common Device Name: INSULATED SHEATH TUBE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer steet 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 7982472
• Report Number: 1418479-2018-00034
• Device Sequence Number: 19131464
• Product Code: GCJ
• UDI-Device Identifier: 04055207016312
• UDI-Public: 04055207016312
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2018
• Report Date (Section F): 10/18/2018

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: 8393933
• Device Catalogue Number: 8393933
• Device Lot Number: 1371904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/18/2018
• Event Location: Other
• Date Report to Manufacturer: 10/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 10/18/2018
• 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
• Date Report Sent to FDA: 10/18/2018