MAUDE Adverse Event Report: RICHARD WOLF GMBH INSULATED SHEATH TUBE

Model Number	8393933
Medical Device Problem Codes	Use of Device Problem (1670); Misassembly During Maintenance/Repair (4054)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/17/2018
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.The following cautions, warnings and checks are listed in the device labeling: warning! do not combine products incorrectly! injuries of the patient, user or others as well as damage to the product are possible.Caution! careful if hf voltage is too high! danger of injury if the insulation of the hf instruments is damaged! exceeding the maximum recurring peak voltage of the hf instrument in conjunction with hf surgical devices and/or selecting the wrong mode of operation can destroy the insulation and cause leakage currents.The patient, user or others can suffer thermal tissue damage.Caution! danger of injury from hf instruments with damaged insulation! the insulation of reprocessed or aged products can be damaged causing thermal tissue damage in/on the patient and user.Hf instruments with damaged insulation must be replaced.Do not re-use.Check the insulation of the hf cable for damage.Replace the hf cable if the insulation is damaged.Check the insulation of the sheath tube for mechanical damage and dielectric breakdown (punctures).Do not use the forceps and scissors if the insulation is damaged.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.A follow up report will be submitted upon receipt of new or additional information.
Event or Problem Description
On september 18, 2018, the user facility reported the following to richard wolf medical instruments (rwmic): while performing lap, lysis of adhesions, there was an arch of electricity and the scissor burned the patient's right fallopian tube.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? yes.Did the issue cause a delay in the procedure being performed that put the patient at risk? slight delay with injury discover and assessment.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.How was the patient anesthetized? general.The device was returned on september 28, 2018, and the evaluation was completed on october 18, 2018.The device was evaluated by visual and functional testing using other components of the modular system - the metzenbaum scissor insert (product number 8393.041) and handle (product number 83930073).The device appeared to be used, insulation on the shaft is a heat-shrink tubing, whereas the insulation is powder coated.Additionally, the device appeared to have been repaired by a third party; both the front and back of the insulation were physically short and did not insulate electrically.It was recommended that the device be scrapped.No manufacturing defect was identified during the evaluation.The other components of the modular system, the metzenbaum scissors and the handle, are considered suspect devices and a report will be submitted for each device.Metzenbaum scissors - product number 8393.041 (mdr 1418479-2018-00035).Sheath tubing - product number 8393933.Handle - product number 83930073 (mdr 1418479-2018-00037).
Additional Manufacturer Narrative
Follow-up report #1 is to provide fda with new and changed information.Richard wolf medical instruments corporation (rwmic) considers this case closed.In the event that rwmic receives additional information a follow up report will be submitted to the fda.
Event or Problem Description
Follow-up report #1 is to provide fda with new and changed information.

• Brand Name: INSULATED SHEATH TUBE
• Common Device Name: INSULATED SHEATH TUBE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 7982479
• Report Number: 1418479-2018-00036
• Device Sequence Number: 1640373
• Product Code: GCJ
• UDI-Device Identifier: 04055207016312
• UDI-Public: 04055207016312
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K935270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2018
• Report Date (Section F): 04/16/2019

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: Health Professional
• Device Model Number: 8393933
• Device Catalogue Number: 8393933
• Device Lot Number: 1248356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/18/2018
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2019
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 04/16/2019
• 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
• Date Report Sent to FDA: 04/16/2019