MAUDE Adverse Event Report: RICHARD WOLF GMBH WORKING ELEMENT

Model Number 8680.205

Device Problems Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Maintenance Does Not Comply To Manufacturers Recommendations (2974); Insufficient Information (3190)

Patient Problems Laceration(s) (1946); Electric Shock (2554)

Event Date 10/13/2015

Event Type  Injury  

Manufacturer Narrative

Many devices were used during the procedure, suspect devices include: working element - mdr9611102-2015-00010.Cutting electrode - mdr9611102-2015-00011.Bipolar cable (not manufactured by (b)(4), however manufacturer was notified of event).Devices currently in route to manufacturer for evaluation.(b)(4) considers this report open and will sent follow-up at a later date.

Event Description

During the final stages of an endoscopic transuretheral electroresection procedure in endovesical hydrosaline solution located at left subtrigonal level, involving homolateral prostatic lobe, a sudden discharge from the electrosurgical unit was noticed.That was followed by haematuria from the outflow channel, with no possibility to fill the bowels with hydrosaline solution anymore.Endoscopic procedure was stopped because laceration of bladder cupola was suspected.Following the immediate intraoperative cystoscopy, proving the laceration of the bladder, abdominal explorative laparotomy was performed, through which a major breaking of bladder cupola was documented, that was sutured.Many device were used during the procedure, suspect devices include: bipolar cable (not manufactured by (b)(4)).Working element - mdr9611102-2015-00010.Cutting electrode - mdr9611102-2015-00011.

Manufacturer Narrative

Follow up #1.The following sections updated/added: product problem, suspect device, all manufacturers, device manufacturers.The work item 8680205 from batch 1238344 was posted in stock on 14mar2014.The corresponding production order 1238344 consists of (b)(4) work items.The company movi was supplied with a working element from this batch on 18mar.2014.Based on the delivery date 18mar2014 results in a theoretical service life of 21 months.The inspection in the responsible department showed that there was moisture underneath the silicone cap and that this led to an uncontrolled current flow during use.Following this test, the work item was oven dried and the test repeated.The work element then withstood the prescribed 3kv high voltage test.The defect found in the working element was caused by insufficient care in instrument reprocessing.For both manual and mechanical reprocessing, the drying step must be carried out.Proven to have a greater care in the drying of the instrument to prevent the flashover on the electrode lock out.In the instructions for use ga-d 342 (in chapters 7,8 and 9), in our opinion, sufficient information on visibility and functional control is available.It is noted at several points in the instructions for use to be carried out checks.Damage to the insulation can lead to uncontrolled current flow.In general, however, it should be noted that hf instruments may only be activated when the part carrying the hf current appears fully in the field of view of the endoscope and the intended application area is contacted.The risk assessment b6 r02 considered possible risks with the corresponding claim size and the assumed probability of occurrence and rated them with an acceptable risk.This rating is still valid considering the current case.Richard wolf (b)(4) considers this matter closed.However, in the event richard wolf (b)(4) receives any additional information a follow up report will be submitted to fda.Richard wolf medical instruments corporation (rwmic) submitting report on behalf of richard wolf (b)(4).

Event Description

Follow up #1.

• Brand Name: WORKING ELEMENT
• Type of Device: WORKING ELEMENT
• Manufacturer (Section D): RICHARD WOLF GMBH; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: oliver ehrlich ; 32 pforzheimer street; knittlingen, 75438 ; GM 75438 ; 043351013
• MDR Report Key: 5272614
• MDR Text Key: 32858853
• Report Number: 9611102-2015-00010
• Device Sequence Number: 1
• Product Code: FDC
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 8680.205
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention