MAUDE Adverse Event Report: RICHARD WOLF GMBH COBRA; FLEXIBLE URETERORENOSCOPES 9,9CH NL680MM

Model Number 7326071

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/05/2020

Event Type  malfunction  

Manufacturer Narrative

There was no harm to the patient.The 7326071 flexible ureterorenoscopes 9,9ch nl680mm with the serial number (b)(4) was manufactured on 13.03.2018.It was delivered to the customer on (b)(6) 2018.The instructions for use ga-d 347 contains a caution to ensure that products must not be combined incorrectly: in general, the user is described in the corresponding instructions for use ga-0347 in chapter 8 it is pointed out that before and after each application a visual and functional check must be carried out.Possible damage of the above type may be withdrawn from the market if these instructions are observed.Hospital staff can easily identify.Instrument was not available for inspection.In our risk analysis a3-2, production-related factors were taken into account, handling and design related hazards with regard to the functional impairment as well as risks due to an unusable the product with the corresponding extent of damage and the assumed probability of occurrence and with an acceptable risk is evaluated.Richard wolf (b)(4) (rw(b)(4)) considers this matter closed.However, in the event rw(b)(4)receives any additional information a follow up report will be submitted to fda.Richard wolf medical instruments corporation (rwmic) submitting report on behalf of rw(b)(4) report on behalf of rw(b)(4).

Event Description

It was reported to rw (b)(4) that on (b)(6) 2020, after the patient was sent to the operating room and was successfully anesthetized and ready for operation, the doctor found that the flexible ureteroscope could not be operated normally, resulting in the failure of the operation.There was no harm to the patient.

• Brand Name: COBRA
• Type of Device: FLEXIBLE URETERORENOSCOPES 9,9CH NL680MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10538487
• MDR Text Key: 207185702
• Report Number: 9611102-2020-00019
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04055207013748
• UDI-Public: 04055207013748
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K980401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/14/2020

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 Operator: Health Professional
• Device Model Number: 7326071
• Device Catalogue Number: 7326071
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1