MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CLICKLINE FORCEPS INSERT

Model Number 33310C

Device Problem Crack (1135)

Patient Problems Unspecified Mental, Emotional or Behavioural Problem (4430); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/19/2022

Event Type  Injury  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.

Event Description

"it was reported that during a vaginal extraction of the uterus with adnexa, where a morcellation was indicated due to the size of the uterus, it was noticed that the forceps was broken and one of the jaws was missing.The missing jaw could not be detected by using x-ray.Therefore, the abdomen had to be opened with a pfannenstiel incision.The jaw was found on the left side of the upper abdomen behind the spleen.The surgery time was prolonged, and the surgery was extended from a laparascopy to a 10cm laparotomy.".Internal karl storz reference number: (b)(4).

Manufacturer Narrative

The device was not sent in for investigation.Therefore, no physical investigation could take place.Based on the failure description, the most probable root cause of the failure is the excessive force applied by the user.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CLICKLINE FORCEPS INSERT
• Type of Device: 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 90245-5017 ; 4242188738
• MDR Report Key: 15925921
• MDR Text Key: 304918299
• Report Number: 9610617-2022-00318
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04048551134092
• UDI-Public: 4048551134092
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 33310C
• Device Catalogue Number: 33310C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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