MAUDE Adverse Event Report: KARL STORZ SE & CO. KG NEEDLE, MEDIUM CURVE, 16.5 CM

Model Number 224302

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 22-0074 corrective action 6.Investigation result: the tips of the needle are bent by mechanical overload.The device is hardened to 520hv5 +/- 25 (47 hrc) - this gives good mechanical strength on one hand, on the other hand it is ductile enough to prevent instant breaking when over loaded.Device is as elastic as designed.There is no indication for material or manufacturing failure.The failure is most probably usage related.The event is filed under internal karl storz complaint id ((b)(4)).

Event Description

It was reported that there was event with a needle.According to the information received, there is a barb on the tip of the needle.No further information available.No patient harm reported.

• Brand Name: NEEDLE, MEDIUM CURVE, 16.5 CM
• Type of Device: NEEDLE, MEDIUM CURVE, 16.5 CM
• 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: 17290705
• MDR Text Key: 318841954
• Report Number: 9610617-2023-00890
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• 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: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 224302
• Device Catalogue Number: 224302
• Device Lot Number: ZQ02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2019
• 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