MAUDE Adverse Event Report: RICHARD WOLF GMBH HANDLE PISTOL SHAPED MONO

Model Number 83930073

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); No Consequences Or Impact To Patient (2199)

Event Date 09/17/2018

Event Type  malfunction  

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 Description

On (b)(6) 2018, the user facility reported the following to richard wolf medical instruments (rwmic): while performing a 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 (b)(4) 2018, and the evaluation was completed on october 28, 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 the sheath tubing (product number 8393933).The device met specification and the reported malfunction could not be verified during evaluation, no issue was found with this component of the modular system.The other components of the modular system, the metzenbaum scissor insert and the sheath tubing, 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 (mdr 1418479-2018-00036); handle - product number 83930073 (mdr 1418479-2018-00037).

Manufacturer Narrative

Follow-up report #1 is to provide fda with new and changed information.New/ changed information: b5, d5, f7, f8, f9, f11, f13,g4, g5, g7, h2, h4, h6, h10.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 Description

Follow-up report #1 is to provide fda with new and changed information.The device was returned on (b)(6) 2018, and the evaluation was completed on (b)(6) 2018.

• Brand Name: HANDLE PISTOL SHAPED MONO
• Type of Device: HANDLE PISTOL SHAPED MONO
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 7982471
• MDR Text Key: 126109113
• Report Number: 1418479-2018-00037
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04055207026618
• UDI-Public: 04055207026618
• Combination Product (y/n): N
• PMA/PMN Number: K935270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/16/2019,09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 83930073
• Device Catalogue Number: 83930073
• Device Lot Number: 1239021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/16/2019
• Distributor Facility Aware Date: 09/18/2018
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2019
• Date Manufacturer Received: 04/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other