MAUDE Adverse Event Report: RICHARD WOLF GMBH MOXY; LASER WORKING INSERT 12/30 ROUND

Model Number 8632284

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 05/23/2022

Event Type  Injury  

Event Description

Richard wolf gmbh complaint reference (b)(4).According to the user facility: "bladder perforation with the laser working insert.Could not be completed endoscopically, urgent laparotomy was performed to repair the patient's bladder." the user facility has not given information about the exact product problem, they have only shared the information about the harm of the patient.The investigation is pending due to not receiving the device at richard wolf gmbh in (b)(4).Rwgmbh awareness date, 13-jun-2022.

Manufacturer Narrative

Richard wolf medical instruments (rwmic) is submitting this mdr on behalf of the device manufacturer, rw gmbh.The device history record was reviewed.The batch #1484575 of the laser working insert 12/30 #8632284 contains 15 pieces of devices and the batch was produced on july 16, 2021.1 piece from the affected batch was delivered to the distributor to (b)(4) on july 26, 2021.There are no records about when it was delivered to the end user or about any maintenance or repair.Between (b)(6) 2019 and (b)(6) 2022, no similar incident and no other complaint were recorded about the device.The device was purchased to user facility via distributor.The distributor has already collected the reported device and will be returning it to richard wolf gmbh (b)(4).However, the device is not available for investigation by 06/22/2022 yet.Rw considers this matter open.A follow-up report will be submitted when the device investigation or product history evaluation has been completed.

Manufacturer Narrative

Richard wolf medical instruments (rwmic) is submitting this mdr on behalf of the device manufacturer, rw gmbh.The device history record was reviewed.The batch #1484575 of the laser working insert 12/30 # (b)(4) contains 15 pieces of devices and the batch was produced on july 16, 2021.1 piece from the affected batch was delivered to the distributor to spain on july 26, 2021.There are no records about when it was delivered to the end user or about any maintenance or repair.Between 01/01/2019 and 06/21/2022, no similar incident and no other complaint were recorded about the device.The device was purchased to user facility via distributor.The distributor has already collected the reported device and will be returning it to richard wolf gmbh, germany.The device was received on 07/11/2022 for investigation.It was examined in the responsible department.According to the findings, the welding seam was welded correctly.There is a deformation and sign of burn at the distal end of the device.The cause is due to a thermal and mechanical overload.The related ifu ga-d 323 / zh / 2018-12 v2.0/pk 18-9377 (translated into english) contains the following applicable warnings for these errors: 7 application caution! the products have only limited strength! applying excessive force will cause damage (e.G.A bending of the endoscope), impairs the function and therefore endangers the patient.Ensure sufficient relaxation of the patient during the intervention! immediately before and after each use, check the products for damage, loose parts and completeness.Make sure that no missing parts remain in the patient.Do not use the products if they are damaged or incomplete or have loose parts.7.2.1 inserting a laser fiber the laser fiber is guided in the working channel, but it is axially and radially freely movable because the working insert does not have a holder or stop to align greenlight¿ laser fibers.Caution! laser probe can rotate through 360°! be careful in particular in the case of: cysto-ureteroscope sheaths with sheath window and resectoscope sheaths with a nib or beveled distal end.When rotating and activating the laser probe within the distal sheath end (nib, window, beveled end) the edges of the sheath and endoscope can be damaged.Activate the laser only after the tip of the laser probe has become fully visible through the scope and contact is made with the intended area to be treated.8 check caution! be careful if products are damaged or in-complete! injuries of the patient, user or others are possible.Run through the checks before and after each use.Do not use the products if they are dam-aged, incomplete or have loose parts.Return damaged products together with any loose parts for repair.Do not attempt to do any repairs yourself.8.1 visual check check instrument and accessories for damage, sharp edges, lose or missing parts and rough surfaces.Before every use, check the ceramic insulation on the distal end of the sheath.Do not use the instruments if they are damaged (cracks, fractures)! check the rubber cap (1.4) for damage and replace if necessary.Any lettering, labeling or identification necessary for the safe intended use must be legible.Missing or illegible inscriptions and labels that can lead to wrong handling and reprocessing must be reinstated.8.2 functional check check the individual instrument for easy assembly and proper functioning of the locking mechanism(s).Replace the instruments if the connection although locked is not secure.Replace the instruments if the connection cannot be locked or is difficult to lock.Check the instrument channels / ports for patency (free passage).Based on the facts described, it can be assumed that the incident described is due to an operating error.A direct connection with our products is not apparent.The risk is known to risk management (b6-2), it is classified as acceptable and the risk mitigation measures are considered effective.The risk has arisen from at least one of the following causes: user error with regard to the instructions for use, deviation from the intended use, improper cleaning or sterilization, incorrectly completed associated documentation or other violations of laws, standards or specifications of richard wolf gmbh, compliance with which was mandatory.The identified defect does not describe a general product problem, non-conformity, negative trend or previously unknown hazards.Since the complaint is about a handling error (thermal and mechanical over-load), a systemic problem is not recognizable and the warnings about the problem described by the customer in the ga-d323 operating manual are considered sufficient, no further investigations or measures on the part of the manufacturer are indicated.Richard wolf medical instruments (rwmic) is submitting this mdr behalf of the device manufacturer, rw gmbh.Rw considers this matter closed.However, if a new information is available, rw will submit a follow-up report.

Event Description

Richard wolf gmbh complaint reference (b)(4).The purpose of this submission is to provide additional informations and results of the device evaluation.

• Brand Name: MOXY
• Type of Device: LASER WORKING INSERT 12/30 ROUND
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; 75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer Contact: zsófia bartholome-nagy ; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• MDR Report Key: 14887201
• MDR Text Key: 295133063
• Report Number: 9611102-2022-00026
• Device Sequence Number: 1
• Product Code: FBO
• UDI-Device Identifier: 04055207018194
• UDI-Public: 04055207018194
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K935163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

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: 8632284
• Device Catalogue Number: 8632284
• Device Lot Number: 1484575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/01/2022
• Supplement Dates Manufacturer Received: 07/11/2022
• Supplement Dates FDA Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other