MAUDE Adverse Event Report: RICHARD WOLF GMBH (GERMANY) SCALPEL 20.5FR CERAMIC SEMICIRCULAR

Model Number 8667.961

Device Problem Break (1069)

Patient Problems Necrosis (1971); Swelling (2091); Device Embedded In Tissue or Plaque (3165)

Event Date 02/13/2018

Event Type  Injury  

Manufacturer Narrative

The scalpel was inspected at (b)(4) for evaluation and the ceramic blade was confirmed to be broken.The scalpel was manufactured about 17 years ago.The medical device 8667.961 has been in the range since sept 20th 1999 and is still distributed.The scalpel type number 8667.961 was reported as a complaint for the last time back in 2010.The scalpel was mechanically overloaded and there were no indications of a material or a manufacturing defect.The ifu for this product informs the user about the material properties of ceramic: "7.2 stricture scalpels important! stricture scalpels with a ceramic cutting edge can be used several times.Stop using the stricture scalpels if the cutting performance deteriorates.Return the stricture scalpels for re-sharpening.To ensure an optimal operation, there must always be enough stricture scalpels at hand.Warning! danger of injury! due to the design and material used, the distal area of stricture scalpels with ceramic blades is sensitive to falls, shocks, or similar mechanical loads.Incorrect use can cause hair cracks, spalling of the ceramic material and/or breakage of the ceramic blade.Injuries to the patient, user or third parties are possible.Observe surface changes and ensure safe handling.Before and immediately after each use, check stricture scalpels for possible damage and completeness.Make sure that no missing parts remain in the patient ceramics are x-ray positive.Do not use damaged stricture scalpels.The ifu, chapter 8 inspection and chapter 8.1 visual inspection, describes controls to be carried out in order to discover damages on the product at an early stage.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.Important! 8.1 visual check: check the products, in particular their distal area, and the accessories for: damage, sharp edges, sharp edges not suitable for the application, loose or missing parts, any inscriptions or identification necessary for the sage intended use must be legible, check the stricture scalpels (6) for possible damage and sharpness, do not use damaged or blunt stricture scalpels." the aware date of 6/21/2018 has to be confirmed; the device was returned to (b)(4) on 6/21/2018 but rwmic is following up with (b)(4) to confirm that this was the first date that they became aware of this incident.All other missing information is being requested and rwmic will provide a follow up report as appropriate.

Event Description

On 8/15/2018 richard wolf medical instruments corporation, hereinafter referred to as rwmic, was made aware of an event from richard wolf (b)(4) hereinafter referred to as (b)(4) of an incident that occurred at a hospital in (b)(6).(b)(4) was notified by (b)(6) authorities on a date yet to be determined that a significant injury occurred during a procedure in the hospital involving a (b)(6) male patient.(b)(4) attempted to contact the user facility to obtain information on the device, product code, lot number but no additional information was available at that time.An optical urethrotomy was performed on the patient on (b)(6) 2018 and at the very beginning of the procedure, just after the urethrotomy had been performed, it was noted that the blade had become dislodged from the end of the instrument and had become embedded in the peri-urethral tissues.The user made repeated attempts to find and remove this blade but was unable to do so, despite using fluoroscopic screening in the operating theatre.Various different scopes were used as well as different types of graspers.The patient suffered a very significant injury as a result of the equipment malfunction and the attempts made to retrieve the blade.He had significant scrotal oedema and went on to become oliguric with an acute kidney injury.He required hemodialysis from (b)(6) 2018 until (b)(6) 2018.A renal biopsy was performed which showed acute tubular necrosis.His renal function returned to normal very slowly after this.His urethral catheter was finally removed on (b)(6) 2018 and he was discharged home on (b)(6) 2018.The doctor saw the patient on the renal day ward on (b)(6) 2018 and again in clinic on (b)(6) 2018 when his serum creatinine was 110 micromol/l and has since dropped to 90 micromol/l.The doctor confirmed that he did a plain kub x-ray prior to the patient's discharge and the blade could still be seen in-situ.

Event Description

Follow up #1 is to provide fda with new and corrected information.

Manufacturer Narrative

(b)(4).Rwgmbh considers this matter closed, should additional information become available, a follow up report will be submitted as required.

• Brand Name: SCALPEL 20.5FR CERAMIC SEMICIRCULAR
• Type of Device: SCALPEL 20.5FR CERAMIC SEMICIRCULAR
• Manufacturer (Section D): RICHARD WOLF GMBH (GERMANY); 32 pforzheimer street; knittlingen, gm 75438 ; GM 75438
• MDR Report Key: 7791287
• MDR Text Key: 117441928
• Report Number: 9611102-2018-00011
• Device Sequence Number: 1
• Product Code: EZO
• UDI-Device Identifier: 04055207019245
• UDI-Public: 04055207019245
• Combination Product (y/n): N
• PMA/PMN Number: K000905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8667.961
• Device Catalogue Number: 8667.961
• Device Lot Number: M612210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Date Manufacturer Received: 03/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR