MAUDE Adverse Event Report: RICHARD WOLF GMBH LASER WORKING ELEMENT PASSIVE

Model Number 8654.282

Device Problems Connection Problem (2900); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Rwmic considers this case open.Rwmic to contact manufacturer and user facility for missing information.Follow up report will be provided upon receipt of new information.

Event Description

On august 7th 2019, the user facility reported the following to richard wolf medical instruments corporation (rwmic): during procedure, laser guide loops are not staying connected during use.Will the device be returned? yes.Was the device being used during a procedure when the issue occurred? yes.Specifically, was the device being used on a patient 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 that put the patient at risk? yes.Was there a similar back-up device available for use? no.Was the scheduled procedure completed? no.How was the patient anesthetized? general.

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.This mdr is being submitted as part of an ongoing retrospective review (remediation) of prior files by rwmic.Follow-up report #1 is to provide fda with missing information, new information, and changed information.New information: see below (section h10) for the results of the device investigation.In addition, the following fields have new information: d9, h6.The results of the device investigation: product appearance: used, broken; complaint condition verified: yes; repeat repair: no, first-time; met specifications: no; test method: functional; equipment used: functional; probable root cause: other, see conclusion; physical findings: parts damaged; conclusion: pin within working element was damaged possibly due to mechanical influences; complaint valid: no, first time; action required: repair, replace parts cleaned and test.The associated instructions for use ga-d333 contain instructions for use, warnings and cautions: 7 use warning! do not reprocess disposable items! the service life of products marked as disposable, i.E.For one single use only, has been designed for only one use in or on a single patient.If disposable items are reprocessed to be used again, this may impair/change the product properties and therefore endanger the patient, user and others.Possible dangers / risk factors: strength problems, damage to the product, severe impairment of the function, substantially increased risk of infection, biocompatibility problems.If a disposable item is reprocessed, the product responsibility lies with the user or reprocessor.In this case, the manufacturer can no longer guarantee the safety and performance of the product.Caution! the products have only limited strength! excessive force will cause damage, impairs the function and therefore endangers the patient.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.7.1 preparations: carry out a visual check: see sections 8 and 8.1 8 checks: caution! be careful if products are damaged or incomplete! injuries of the patient, user and others are possible.Run through the checks before and after each use.Do not use the products if they are damaged, 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 the instruments and accessories for the following: damage, sharp edges, loose or missing parts, rough surfaces.Any inscriptions or identification necessary for the safe intended use must be legible.To prevent wrong handling or reprocessing, any illegible lettering, labeling or identification must be reinstated.Rwmic considers this mdr closed.Should rw receive new information, a follow-up report will be submitted.

Event Description

The purpose of this submission is to report the results of the device investigation.See manufacturers narrative (h10).

• Brand Name: LASER WORKING ELEMENT PASSIVE
• Type of Device: LASER WORKING ELEMENT PASSIVE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: oliver ehrlich ; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 8972604
• MDR Text Key: 206984307
• Report Number: 1418479-2019-00046
• Device Sequence Number: 1
• Product Code: FDC
• UDI-Device Identifier: 04055207018781
• UDI-Public: 04055207018781
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/06/2019,05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8654.282
• Device Catalogue Number: 8654.282
• Device Lot Number: 1411016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/06/2019
• Distributor Facility Aware Date: 08/07/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/06/2019
• Initial Date Manufacturer Received: 08/16/2019
• Initial Date FDA Received: 09/06/2019
• Supplement Dates Manufacturer Received: 08/16/2019
• Supplement Dates FDA Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention