MAUDE Adverse Event Report: RICHARD WOLF GMBH CUTTING ELECTRODE

Model Number 4622.2513

Device Problem Insufficient Information (3190)

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

Event Date 10/13/2015

Event Type  Injury  

Manufacturer Narrative

Many device 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).Cutting electrode was disposed of by the hospital unable to perform investigation.(b)(4) considers this matter closed.If additional information is received a follow up report will be submitted to the fda.

Event Description

During the final stages of an endoscopic transurethral electroresection procedure in endovescical 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: adverse event or product problem: selected adverse event.Outcomes attributed to adverse event: selected required intervention to prevent permanent impairment/damage (devices).Selected serious injury.

Event Description

Follow up #1, add information.

• Brand Name: CUTTING ELECTRODE
• Type of Device: CUTTING ELECTRODE
• 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: 5272282
• MDR Text Key: 32858309
• Report Number: 9611102-2015-00011
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• 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 Expiration Date: 05/31/2020
• Device Model Number: 4622.2513
• Device Lot Number: 51002840
• 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: 05/21/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention