MAUDE Adverse Event Report: RICHARD WOLF GMBH COBRA VISION; SENSOR URETERORENOSCOPE

Model Number 7356071

Device Problems Blocked Connection (2888); Mechanical Jam (2983)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Rwmic considers this case open.A follow up will be provided upon completion of the device evaluation and/or receipt of additional information.

Event Description

On july 24, 2019, the user facility reported the following to richard wolf medical instruments corporation (rwmic): during a procedure, "200 trac tip" fiber was advanced through both working channels and it got hung up and would not advance all the way.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? unknown.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? yes.Was the scheduled procedure completed? yes.How was the patient anesthetized? general.

Event Description

The purpose of this submission is to report the results of the device investigation.According to the investigation completed by the manufacturer, richard wolf gmbh: product appearance: other: used.Complaint condition verified: yes.Repeat repair: no.Met specifications: no.Test method: visual, functional.Equipment used: pa-01-001-3033'.Probable root cause: user error/misuse, user handling.Complaint valid: no - mechanical influences.Action required: repair.Physical findings: the current review in the department found that the objective lens had broken out and the proximal tube had been incised.Conclusion: the cause of the broken objective lens and the torn proximal tube is due to mechanical influences.The user is informed in the related ifu ga-d 370 / usa / 2015-04 v3.0 / eco 2015-0069 about the cautions and functional checks of the device: caution! to avoid damage to the laser fiber channel (17), - do not use force to insert or withdraw the laser fiber (x) into/from the laser fiber channel (18).- insert and withdraw the laser fiber (x) through the laser fiber channel only if the instrument sheath (5) is straight and the instrument tip (4) is straight (17).Angle (deflect) the urs only when the laser fiber (x) is correctly positioned.Caution! to avoid damage to the working channel (1) and the biopsy valve set (10), - do no apply force when inserting instruments in the working channel (1) or withdrawing them from the latter (fig.22a).- insert and withdraw auxiliary instruments through the working channel (1) only when the instrument tip (4) is straight.(fig.22b).Angle (deflect) the urs only after the auxiliary instrument has become fully visible through the scope.It is then possible to further extend the auxiliary instrument with the instrument tip (4) in angled position, but it may only be retracted up to shortly before the instrument tip (4) (fig.22c).7.6.2 inserting the urs via a guide wire.Caution! danger of destroying the working channel (1) due to the rigid proximal end of the guide wire! when inserting the urs into the operating field via the proximal rigid end of the guide wire, incorrect handling may destroy working channel (1).To avoid the above, before insertion make sure that: - the locking lever / brake (12.2) is released (see section 7.3.1); - the instrument sheath (5) and the instrument tip (4) are straight; - the urs is only inserted via the working channel (1).

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 any new, missing or changed information.New information: b5 - results of the device investigation, h6- adverse event codes changed information: h8 - usage of device - changed to reuse missing information: richard wolf requested additional information as part of due diligence, no further information was provided by the user facility.Rwmic considers this mdr closed.Should rw receive new information, a follow-up report will be submitted.

• Brand Name: COBRA VISION
• Type of Device: SENSOR URETERORENOSCOPE
• 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: 8927182
• MDR Text Key: 200389642
• Report Number: 1418479-2019-00041
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04055207054864
• UDI-Public: 04055207054864
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2019,05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 7356071
• Device Catalogue Number: 7356071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/23/2019
• Distributor Facility Aware Date: 07/24/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2019
• Date Manufacturer Received: 07/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2017
• 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