MAUDE Adverse Event Report: RICHARD WOLF GMBH PRINCESS; CUTTING ELECTRODE BIPOLAR SINGLE USE

Model Number 46531313

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

User facility returned the device to rw mic on 06/30/2020, and currently pending evaluation of the devices.Rw mic will reach out to the user facility and the manufacturers for additional information.Upon receiving additional information a follow-up report will be submitted.

Event Description

It was reported by the user facility: during the procedure the cutting loops tip frayed and melted.There was no patient injury and the case was completed.Will the device be returned? yes.Was the device being used during a procedure when the issue occurred? yes.Was there any injury or illness to patient or other personnel due to issue? no.Did the issue cause a delay in the procedure being performed? yes.Did the delay put the patient at risk? no.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.

Event Description

Follow-up report #1 is to provide fda with missing information, new information, and/or changed information.Please refer to the manufacturers narrative for details.

Manufacturer Narrative

Follow-up report #1 is to provide fda with missing information, new information, and/or changed information.Changed information: the following fields have changed information: b4, b5, f1, f7, f13, g7, h3, h6, h7, h10.Rwmic completed its investigation of the device.Rwmic received and visually evaluated the device.The reported condition was verified.The probable root cause was attributed to user error.The device was scrapped and replaced.Device labeling was reviewed for patient code and device codes, see below: patient code: not applicable, no patient problem was reported.Device code: ifu was reviewed ifu includes a caution for combining products: do not combine products incorrectly! injuries of the patient, user or others as well as damage to the product are possi­ble.The different products may only be used together if their intended uses and the relevant technical data (working length, diameter, peak voltage, etc.) are the same.Ifu includes a warning for possible dangers/risk factors: strength problems; damage to the product; severe impairment of the function; substantially increased risk of infection 'biocompatibility problems.Ifu includes a caution for limited strength."excessive force will cause damage, impair the function, and therefore endanger the patient.Immediately before and after each use, check products for damage, loose parts, and completion.Do not use the products if they are damaged or incomplete, or have loose parts".The ifu includes a "note" about "excessive power settings can cause clearly increased electrode wear.We recommend starting at a lower power setting to determine the optimum power setting" rwmic considers this complaint and mdr closed.Follow-up reports will be sent to fda as required.Attachment: [ga-d349 usa_6.0 (14-0506).Pdf].

• Brand Name: PRINCESS
• Type of Device: CUTTING ELECTRODE BIPOLAR SINGLE USE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10289878
• MDR Text Key: 199309952
• Report Number: 1418479-2020-00015
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04055207048962
• UDI-Public: 04055207048962
• Combination Product (y/n): N
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/17/2020,08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2024
• Device Model Number: 46531313
• Device Catalogue Number: 46531313
• Device Lot Number: 4500277054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/17/2020
• Distributor Facility Aware Date: 06/24/2020
• Device Age: 1 YR
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 07/17/2020
• Date Manufacturer Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1