MAUDE Adverse Event Report: KARL STORZ SE & CO. KG KNIFE, STRAIGHT

Model Number 27068K

Device Problem Fracture (1260)

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

Event Date 06/04/2018

Event Type  malfunction  

Event Description

It was reported that the blade section of the instrument broke off the shaft section.The instrument was attached to the working element part of the urology resectoscope.The blade broke off during the patient procedure.

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 20-0052 corrective action 6.The blade is lateral bent, completely blunt and broken at the junction to the rail.The broken surface is not discoloured, which indicates a fresh break - the appearance of the break points towards overload.The ifu contains warnings towards these damages - special the lateral bending has a separate section.The event is filed under internal karl storz complaint id (b)(4).

• Brand Name: KNIFE, STRAIGHT
• Type of Device: KNIFE, STRAIGHT
• 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: 16950075
• MDR Text Key: 315490217
• Report Number: 9610617-2023-00619
• Device Sequence Number: 1
• Product Code: EZO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K934730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27068K
• Device Catalogue Number: 27068K
• Device Lot Number: GF01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2004
• 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