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

Model Number 27069K

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 20-0052 corrective action 6.As the device was not returned and no further information was received the case will be closed without any physical investigation.No indications for a systematic issue.If further information or the product will become available, the case will be reopened and re-evaluated.The event is filed under internal karl storz complaint id (b(4).

Event Description

It was reported that there was event with a knife, straight.According to the information received, at the time of use of the item 27069k, customer noticed that the knife had a loose end, making it impossible to use.Additional information is not available.

• 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: 16950069
• MDR Text Key: 315463494
• Report Number: 9610617-2023-00624
• Device Sequence Number: 1
• Product Code: EZO
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K934730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2023

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: 27069K
• Device Catalogue Number: 27069K
• Device Lot Number: WS01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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