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

Model Number 27068K

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/03/2020

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 scalpel was returned with 2 pieces.The distal knife was broken off from the tube of the scalpel.Upon evaluation it was found that at the broken area of the knife there are signs of discoloration and rus.It could be the evidence of either corrosion or exerting too much force to the welding joint.In addition, the distal end of knife was bend which could be the result of high lateral force applied.The root cause most probably which may cause damage and breakage of the knife is due to exerting too much force, especially lateral force the event is filed under internal karl storz complaint id (b)(4).

Event Description

It was reported that the surgeon became aware that there is no instrument tip after the surgery (optical urethrotomy).Broken tip was found in patients bladder via x-ray when the patient was in the recovery room.Lt was removed by cystoscopy with foreign body removal at once.Second surgery (cystoscopy to remove remaining broken tip in patient bladder) was performed.

• 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: 16950067
• MDR Text Key: 315425556
• Report Number: 9610617-2023-00621
• Device Sequence Number: 1
• Product Code: EZO
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 27068K
• Device Catalogue Number: 27068K
• Device Lot Number: YV01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2014
• 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