MAUDE Adverse Event Report: KARL STORZ SE & CO. KG OPTICAL FORCEPS, FOR BIOPSY

Model Number 27072A

Device Problem Break (1069)

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

Event Date 05/30/2018

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.The bayonet handle has broken off signs of corrosion can be seen at the fracture.There is also an impact point on the broken part.The handle was probably mechanically overloaded.There is corrosion at the point of breakage.In general, the damage does not pose any risk.The event is filed under internal karl storz complaint id (b)(4).

Event Description

It was reported that there was event with a optical forceps, for biopsy.According to the information received, the surgeon was using the instrument and a small metal part broke off near the handpiece of the instrument.This part was not inside the patient.No injury to any person.

• Brand Name: OPTICAL FORCEPS, FOR BIOPSY
• Type of Device: OPTICAL FORCEPS, FOR BIOPSY
• 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: 17290703
• MDR Text Key: 318842139
• Report Number: 9610617-2023-00909
• Device Sequence Number: 1
• Product Code: OCZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K950434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/21/2023

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: 27072A
• Device Catalogue Number: 27072A
• Device Lot Number: OT11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2016
• 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