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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CLICKLINE LAPAROSCOPE, GENERAL PLASTIC SURGERY

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KARL STORZ SE & CO. KG CLICKLINE LAPAROSCOPE, GENERAL PLASTIC SURGERY Back to Search Results
Model Number 33310C
Device Problems Break (1069); Defective Component (2292); Component Missing (2306); Tip (3123)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 01/31/2020
Event Type  Malfunction  
Event Description

While grasping tissue with a laparoscopic bowel grasper, the instrument's metal tip broke and was lost inside the patient. X-ray was required to locate the missing piece of the instrument and was used to assist the attending surgeon in removing the instrument from the patient's abdomen. This instrument was tagged as defective and removed from the surgical field.

 
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Brand NameCLICKLINE
Type of DeviceLAPAROSCOPE, GENERAL PLASTIC SURGERY
Manufacturer (Section D)
KARL STORZ SE & CO. KG
2151 e. grand ave
el segundo CA 90245
MDR Report Key9732349
MDR Text Key180144601
Report Number9732349
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 02/05/2020,02/03/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/20/2020
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number33310C
Device Catalogue Number33310C
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/05/2020
Event Location Hospital
Date Report TO Manufacturer02/20/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 02/20/2020 Patient Sequence Number: 1
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