MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK/S-LINE; CUTTING ELECTRODE BIPO 22FR 12/30°

Model Number 4622.1333

Device Problem Mechanical Jam (2983)

Patient Problems Perforation (2001); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2022

Event Type  malfunction  

Manufacturer Narrative

Initial situation: the customer complains about a working element passive bipo 0/12/30° 8680.225 and a cutting electrode bipo 22ch 12/30° 4622.1333.According to the customer, the electrode jammed in the working element during one application, causing the bipolar electrode 4622.1333 to kink.The bladder of a patient was injured in the process.More detailed descriptions of the exact incident are not available.Number of reprocessing cycles of the working element and other products used in combination are not available.Investigations/analysis: the working element 8680.225 sent in does not have any functional limitations, in particular no constriction indicating jamming of the electrode.The 4622.1333 electrode can be inserted and moved without any problems.The damage pattern of the electrode indicated by the customer is not comprehensible.There are visual defects on the ae due to corrosion.In addition, the working element has a marking which does not correspond to the specification of r.Wolf.The damage pattern cannot be reconstructed with the underlying information.Damage to the electrode due to a non-functional working element, as presented by the customer, is not achievable if the function test is carried out correctly before use.The visual defects indicate errors during preparation.The ga-d342 instructions for use contain appropriate instructions for carrying out the reprocessing and also warnings for handling damaged and non-functioning products.7 application warning limited stability of the products! excessive use of force leads to damage, impairs the function and thus endangers the patient.Always hold the cable by the plug for plugging and unplugging, never pull on the hf cable.Caution limited stability of the products! excessive application of force will cause damage, impair the function and thus endanger the patient.Check products immediately before and after use for damage, loose parts and completeness.No missing parts may remain in the patient.Do not use products that are damaged, incomplete or have loose parts.Use them again.8.1 visual inspection check products and accessories for: damage, sharp edges, loose or missing parts, rough surfaces.Pay particular attention to the insulation.Labels and markings required for safe and proper use must be legible.-missing, illegible inscriptions and markings that lead to errors in handling and reprocessing must be restored.8.2 functional check 1.Check compatibility of individual components.2.Verify ease of assembly and locking mechanism of each product.Replace products if the connection does not hold despite locking, does not lock or can only be locked with difficulty.3.Check the fit of the electrode (13): insert working element (11) (12) into resectoscope shaft (chapter 7.1.10 inserting working element (11) (12) into resectoscope shaft - models (a) - (e)) and pull electrode (13) back completely by means of working element (11) (12).In this end position, the clip (u) of the electrode must be approx.1 mm behind the edge of the shaft.This is the only way to ensure proper ablation of the tissue.4.Check the function of the hf bipolar connection cable (14) in connection with the s(a)line-resectoscope and the hf surgical unit.5.Check the rinsing and suction function.6.Check the entire system for leaks and continuity.Basically, handling-related, as well as design-related and manufacturing-related risks of a product that cannot be used are considered in the risk assessment of these electrodes with the corresponding extent of damage and the assumed probability of occurrence, and are assessed as an acceptable risk.This electrode 4622.1333 has been included in the sales program since 10.05.2007 and there are no comparable complaints of this type worldwide.Rwgmbh will submit a follow-up report if new information becomes available.

Event Description

Richard wolf complaint reference number (b)(4).The user reported the following: during a tur-b, a sham defect was evident, the sling/sling slit did not slide back on manual command.A perforation of the bladder occurred.This resulted in a prolongation of the operation time.The procedure could be terminated by replacing the instrumentation.There was no prolonged hospitalization and the patient suffered no permanent damage.Rwgmbh mdr awareness date: (b)(6) 2022.

• Brand Name: SHARK/S-LINE
• Type of Device: CUTTING ELECTRODE BIPO 22FR 12/30°
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438, knittlingen, germany ; GM
• Manufacturer Contact: heiko seider-biedermann ; pforzheimer strasse 32; d-75438, knittlingen, germany ; GM
• MDR Report Key: 15760952
• MDR Text Key: 307264658
• Report Number: 9611102-2022-00057
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04055207048870
• UDI-Public: 04055207048870
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2022

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: Other
• Device Model Number: 4622.1333
• Device Catalogue Number: 4622.1333
• Device Lot Number: 1496858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2022
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2022
• 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