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

Model Number 27069K

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/15/2018

Event Type  Injury  

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 20-0052 corrective action 6.Investigation results: the rail of the blade is completely bent, torn and broken - the insulation shows a point, where it has been clamped somehow.The blade itself is broken - the area around the break shows some rust marks.The broken surface shows a ductile appearance - this indicates an overload break.The broken blade was not enclosed in return shipment.Conclusion: the knife has been mechanically destroyed before breakage.It shows several pre-damages.In addition the device was manufactured 16 years ago.Rust can be seen on the broken surface indication for some kind of pre damage and a final overlaid breakage.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, the device broke during urology surgery and the broken piece was left in patient.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: 16950081
• MDR Text Key: 315439750
• Report Number: 9610617-2023-00625
• Device Sequence Number: 1
• Product Code: EZO
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27069K
• Device Catalogue Number: 27069K
• Device Lot Number: DH02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2002
• 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): Required Intervention