MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOSCOPIC FORCEPS, BIOPSY, LAPAROSCOPE, RIGID; CLICKLINE FORCEPS INSERT

Model Number 33310CC

Device Problems Crack (1135); Detachment of Device or Device Component (2907)

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

Event Date 11/17/2023

Event Type  malfunction  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.Internal karl storz reference number: (b)(4).

Event Description

It was reported that the forceps broke off and fell into the patients abdominal cavity.The patient had to be x-rayed to locate the fragment.The procedure was prolonged about 15 till 60 minutes.The fragment was successfully retrieved.No death or (unanticipated) serious deterioration in state of health reported.

Manufacturer Narrative

The product was returned on (b)(6) 2023.The investigation of the product was completed on (b)(6) 2024.The investigation found one of the branches of the returned article has broken off.There are traces of corrosion on the surface, which may indicate incorrect processing.The material may have been weakened over the years by the corrosion, including at the point of breakage, which led to the branch breaking.The most probable root cause is an operating error due to wear and tear and overloading.

• Brand Name: ENDOSCOPIC FORCEPS, BIOPSY, LAPAROSCOPE, RIGID
• Type of Device: CLICKLINE FORCEPS INSERT
• 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: 18378551
• MDR Text Key: 331291612
• Report Number: 9610617-2023-00400
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K935071
• 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,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 33310CC
• Device Catalogue Number: 33310CC
• Device Lot Number: ME58
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 02/15/2024
• Supplement Dates FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2005
• 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