MAUDE Adverse Event Report: KARL STORZ SE & CO. KG 26FR FIXED INNER TUBE W/CERAMIC INSULATION; RESECTOSCOPE INNER SHEATH TUBE

Model Number 27040GP1

Device Problem Material Fragmentation (1261)

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

Event Date 07/05/2022

Event Type  malfunction  

Manufacturer Narrative

The instrument in question will not be returned for investigation as it was discarded.The most probable root cause is overloading the device.

Event Description

As per a manufacturer incident report #(b)(4) received from the factory in germany: during a prostate resection, the metal end piece of the bipolar cutting snare broke off.The broken snare was immediately replaced with a new one to continue the surgery.Both during and after surgery, attempts were made to find the missing 2-3 mm piece of the broken loop.After a careful cystoscopy, the surgeon could not detect any metal fragment in the bladder.It may have come out during the removal of the instrument and subsequent numerous bladder irrigations.Unfortunately, a careful search for the fragment in the surgical gowns and the resected organic material was also not successful.

• Brand Name: 26FR FIXED INNER TUBE W/CERAMIC INSULATION
• Type of Device: RESECTOSCOPE INNER SHEATH TUBE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 15138839
• MDR Text Key: 297182103
• Report Number: 9610617-2022-00133
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K061541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 27040GP1
• Device Catalogue Number: 27040GP1
• Device Lot Number: WO48
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2021
• 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): Required Intervention
• Patient Sex: Male