MAUDE Adverse Event Report: RICHARD WOLF GMBH BIVAP ELECTRODE BIPO

Model Number 46300223

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 law suit 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 1418479-2018-00052), 46300223 bivap electrode bipo 22fr 12/30 (mdr), 46300243 bivap electrode bipo 24-26fr 12/30 (1418479-2018-00054).

• Brand Name: BIVAP ELECTRODE BIPO
• Type of Device: BIVAP ELECTRODE BIPO
• Manufacturer (Section D): RICHARD WOLF GMBH; 32 pforzheimer street; knittlingen, 70438 ; GM 70438
• Manufacturer (Section G): RICHARD WOLF GMBH; 32 pforzheimer street; knittlingen, 70438 ; GM 70438
• Manufacturer Contact: oliver ehrlich ; 32 pforzheimer street; knittlingen, 70438 ; GM 70438
• MDR Report Key: 8237969
• MDR Text Key: 132775901
• Report Number: 1418479-2018-00053
• Device Sequence Number: 1
• Product Code: JOS
• UDI-Device Identifier: 04055207048931
• UDI-Public: 04055207048931
• Combination Product (y/n): N
• Reporter Country Code: US
• 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

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 46300223
• Device Catalogue Number: 46300223
• 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
• Date Manufacturer Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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