MAUDE Adverse Event Report: RICHARD WOLF GMBH PRINCESS; CUTTING ELECTRODE BIPO 21FR

Model Number 46531313

Device Problem Material Disintegration (1177)

Patient Problem Insufficient Information (4580)

Event Date 09/22/2022

Event Type  malfunction  

Manufacturer Narrative

Rwgmbh will submit a follow-up report if new information becomes available.

Event Description

Rwmic reference complaint no.(b)(4).On october 20, 2022, richard wolf medical instruments corp.(rwmic) received a medsun mandatory and voluntary report # (b)(4) regarding product id# 46531313, lot#21003675.Description of event: the tip of the loop (wire part) noted missing, may have disintegrated.Currently, requests for additional information from the user facility have been unsuccessful.Rwmic mdr awareness date: 20-oct-2022.

Manufacturer Narrative

The device has not been returned by the user facility.The root cause of the device problem "loop broke during use" cannot be determined at this time.The reported cutting electrode bipo 21fr, part 46531313, is from batch 21003675 and was manufactured on 27/jan/2022.No issue during production and no further complaints were received from the reported batch.In general, the user is advised in the relevant ifu ga-d 349 /en-us/ 2015-02 v6.0 / eco 2014-0506 about the limit strength of the device in section 7 use and about the danger if the electrode is activated in air or gas bubble as well as about the incorrectly chosen hf output power in section 7.2.5 hf - application (monopolar / bipolar).Also there are safety notices in section 7.2.5.2 hf application (bipolar) about the caution regarding too high hf voltage / power, about thermal damage and distal wear to the electrode due to continuous activation of the bivap electrode as well as about increased electrode wear due to excessive power setting.The subject issue of "loop broke during use" is present in the p08fo015 risk assessment bb2-3: non-reusable resecting electrodes, rev.: 05.The overall probability of occurrence for this issue remains at previously defined levels and overall risk of the device remains in the acceptable category.

• Brand Name: PRINCESS
• Type of Device: CUTTING ELECTRODE BIPO 21FR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer Contact: pforzheimer strasse 32; d-75438, knittlingen, germany
• MDR Report Key: 15760364
• MDR Text Key: 308143869
• Report Number: 9611102-2022-00059
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04055207048962
• UDI-Public: 04055207048962
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 46531313
• Device Catalogue Number: 46531313
• Device Lot Number: 21003675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Race: White