MAUDE Adverse Event Report: RICHARD WOLF GMBH WORKING ELEMENT PASSIVE BIPO

Model Number 8680.224

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

Patient Problem Burn, Thermal (2530)

Event Date 11/30/2016

Event Type  Injury  

Manufacturer Narrative

Rwmic considers this case open.The user facility and manufacturer will be contacted again in an effort to collect missing information.

Event Description

On (b)(6) 2018, richard wolf medical instruments corporation (rwmic) was served with a patient lawsuit involving a "button type bipolar prostate resector and/or electrosurgical generator".On (b)(6) 2016, the patient underwent a procedure described as "cystoscopy with urethral dilation, transurethral resection/ablation of prostate with bipolar".During said procedure, the patient was under general anesthesia and suffered thermal injury to their bladder and urethra.At this time, the involvement of richard wolf products has not been confirmed.However, the following are considered suspect products and mdrs will be submitted for each until the user facility is able to confirm that no richard wolf products were involved: 8680.225 working element passive bipo 0/12/30 (mdr 1418479-2018-00051), 8680.224 working element passive bipo 0/12/30 (mdr), 46300223 bivap electrode bipo 22fr 12/30 (mdr 1418479-2018-00053), 46300243 bivap electrode bipo 24-26fr 12/30 (1418479-2018-00054).

• Brand Name: WORKING ELEMENT PASSIVE BIPO
• Type of Device: WORKING ELEMENT PASSIVE BIPO
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: oliver ehrlich ; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 8237997
• MDR Text Key: 132775793
• Report Number: 1418479-2018-00052
• Device Sequence Number: 1
• Product Code: FDC
• UDI-Device Identifier: 04055207042946
• UDI-Public: 04055207042946
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/10/2019,12/10/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: 8680.224
• Device Catalogue Number: 8680.224
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/10/2019
• Distributor Facility Aware Date: 12/10/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2019
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR