MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER CERAMIC TUBE; 26FR. FIXED INNER TUBE

Model Number 27040XA

Device Problem Material Fragmentation (1261)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2022

Event Type  malfunction  

Event Description

The manufacturer's complaint reference number for this case is (b)(4).I was called to or 1 today for an issue with an instrument being used for a trans urethral prostate resection.The bipolar working element, #26 continuous flow resectoscope and the 30degree cystoscope were damaged during the surgery.Part of the ceramic tip on the sheath of the resectoscope was broken inside the prostate.They managed to remove that piece and when i had the scrub tech piece it back together to see if we had all the pieces, it was found that we were missing a small portion of the ceramic tip.Dr.The surgeon checked the bladder, irrigated the bladder and prostate out thoroughly, & examined the screen in the drape for this piece.We could not locate it anywhere.An x-ray was performed and nothing was seen on x-ray.Also, the bipolar working element was fused onto the scope.You could see where there was a burn mark on the scope and also on the collected piece of ceramic.During the time that this was happening the or nurse reported that they were seeing some interference on the video monitors.I did question all in the room if they ever actually saw any arcing of electricity during this time.Everyone stated that they had not.No harm to the patient that we are aware of.The procedure was completed with another set up.

Manufacturer Narrative

The affected product has been requested to be returned for investigation but was not yet returned.When the affected product has been returned to the manufacturer an investigation will be conducted.

Manufacturer Narrative

Evaluation findings: the ceramic tip is broken, and black residue was found on remaining piece of tip.The stopcock hole has staining on the rim and there are multiple small dents on the shaft.The product lot code is from 2017 and has been in the facility for 5 years.The related ifu warning: rough handling and sharp blows to the beak can cause cracks or breaks.Before and after each procedure, inspect the ceramic beak by holding it against a light to determine if there are any visible fractures, cracks, or other abnormalities.Do not use a sheath with any signs of damage to the ceramic insulation as it may fail in use and cause injuries to the patient.

• Brand Name: INNER CERAMIC TUBE
• Type of Device: 26FR. FIXED INNER TUBE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo
• MDR Report Key: 15502113
• MDR Text Key: 301162208
• Report Number: 9610617-2022-00271
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551076521
• UDI-Public: 4048551076521
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27040XA
• Device Catalogue Number: 27040XA
• Device Lot Number: VS05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2017
• 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): Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 129 KG