MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH, FOR 27040 SD/SL

Model Number 27040XA

Device Problem Break (1069)

Patient Problem Perforation (2001)

Event Date 04/03/2024

Event Type  Injury  

Manufacturer Narrative

The reported device is pending to be returned for evaluation.Once the evaluation of the reported device is complete, a supplemental report will be made to the fda.This complaint will be tracked and trended.The event is filed under internal karl storz complaint id (b)(6).

Event Description

It was reported that the patient's bladder was discovered to be perforated after the cysto fulguration procedure.3/4 way through the procedure, the surgeon notice the inner sheath's ceramic tip got broken.Another set of instrument was used to finish the procedure.After the procedure, it was noticed that the patient's bladder might be perforated.X-ray was taken and confirmed that the patient had a perforation.Upon evaluation of the patient's condition, the surgeon concluded that the bleeding was minor and open surgery was not necessary.Catheter was used to draw the blood instead.The surgeon suspected that the sharp edges of the broken sheath might have caused the perforation of patient's bladder.The broken pieces were recovered from the patient.The patient was brought back in the next day for further evaluation.

• Brand Name: INNER SHEATH, FOR 27040 SD/SL
• Type of Device: INNER SHEATH, FOR 27040 SD/SL
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave.; el segundo, CA 90245
• MDR Report Key: 19177758
• MDR Text Key: 340999593
• Report Number: 9610617-2024-00120
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• 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; Required Intervention
• Patient Sex: Male