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

Model Number 27069K

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/13/2018

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.The knife is completely dull and shows signs of corrosion.The fracture surface shows discoloration.Due to the lack of cutting power, the knife was probably pressed on too hard and the through-hardened knife broke off.The fracture surface shows discoloration - possibly an indication of prior damage.The event is filed under internal karl storz complaint id (b)(6).

Event Description

It was reported that there was event with a knife, straight according to the information received, the incident occured by performing optical urethrotomy for a patient with a dense bulbar urethral stricture.As made cut, felt blade snap.Distal 2.5 cm approx.Had broken off and was lying within the lumen of the urethra.Changed to cytoscope and picked up the broken blade with biopsy forceps and removed it.Continued to do full cystoscopy.There was no patient harm: as this was recognised, and blade removed, no harm to patient additional patient 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: 16950076
• MDR Text Key: 315438048
• Report Number: 9610617-2023-00618
• 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: 05/17/2023

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: FB01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2008
• 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