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

Model Number 27040XA

Device Problems Break (1069); Dent in Material (2526)

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

Event Date 04/21/2023

Event Type  Injury  

Event Description

It was reported that during tur-v surgery, the ceramic insert of the cystoscope liner of the tur jglesias set no.16048 loses its tip.Surgery is prolonged to remove the foreign body, no consequences for the patient.If the foreign body could not have been removed endoscopically, it would have been necessary to subject the patient to a laparoscopy or laparotomy with the risks related to these procedures, considering that we are talking about a defecated elderly patient with numerous pathologies and extensive bladder carcinoma.

Manufacturer Narrative

Based on the damage shown above, the breakage of the ceramic beak may have been caused by the inner shaft being pulled out of the outer shaft at an angle.When the inner shaft is pulled out of the outer shaft at an angle, this presses the ceramic against the outer shaft and can cause breakage.The shaft also has very severe pressure marks, which is due to a very high force being applied.In addition, the instructions for use state that the ceramic beak should be checked for damage before use.The event is filed under internal karl storz complaint id: (b)(6).

• Brand Name: INNER SHEATH, FOR 27040 SD/SL
• Type of Device: ENDOSCOPE SHEATH, REUSABLE
• 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: 17241135
• MDR Text Key: 318263881
• Report Number: 9610617-2023-00142
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551076521
• UDI-Public: 4048551076521
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K221893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• 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: PN01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2022
• 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