MAUDE Adverse Event Report: KARL STORZ SE & CO. KG PICK, 90°, 1 MM, 16 CM

Model Number 225210

Device Problem Fracture (1260)

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

Event Date 11/23/2023

Event Type  Injury  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.Internal karl storz reference number: (b)(4).

Event Description

It was reported that the tip broke off during use.The surgeon could not find the broken tip and it could potentially have remained in the patients ear.No harm to the patient.The procedure could be completed successfully.

Manufacturer Narrative

As the article was manufactured in february 2004 according to the date of manufacture and is therefore 20 years old, there is a high probability that it is due to wear and tear.Point 9 of the reconditioning instructions states that depending on the reconditioning and chemicals used, the service life of the item may be affected.It is possible that the tip has been damaged at the distal end during reprocessing due to a combination of excessive force and slight corrosion and that micro-cracks have formed over time, causing the tip to break off during surgery.It is therefore important to follow the instructions in point 9.1 of the reprocessing instructions and to check the article for damage and function before each use.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: PICK, 90°, 1 MM, 16 CM
• Type of Device: PICK, 90°
• 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: 18661817
• MDR Text Key: 334794550
• Report Number: 9610617-2024-00029
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EXEMPT
• 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,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 225210
• Device Catalogue Number: 225210
• Device Lot Number: BF01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2004
• 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
• Patient Outcome(s): Other