MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG TROCAR

Model Number 26031G

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2014

Event Type  malfunction  

Event Description

Allegedly, during a hip diagnostic arthroscopy procedure, the trocar shaft broke in half and a piece fell into the patient.The doctor immediately removed it; and the procedure was completed with no patient injury.

Manufacturer Narrative

The instrument has not been returned for evaluation.We are following up with the customer to have the instrument returned.

• Brand Name: TROCAR
• Type of Device: TROCAR
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG; tuttlingen ; GM
• Manufacturer (Section G): KARL STORZ GMBH & CO. KG; mittelstrasse 8; tuttlingen 7850 3; GM 78503
• Manufacturer Contact: susie chen ; 2151 e. grand ave.; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 4853596
• MDR Text Key: 5944430
• Report Number: 9610617-2015-00039
• Device Sequence Number: 1
• Product Code: HIN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K871745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/12/2015

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: 26031G
• Device Catalogue Number: 26031G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR