MAUDE Adverse Event Report: KARL STORZ GMBH & CO CUSHIERI LIVER RETRACTOR

Model Number 30623U

Device Problem Material Separation (1562)

Patient Problem Liver Laceration(s) (1955)

Event Date 03/09/2015

Event Type  malfunction  

Event Description

Allegedly, while performing a laparoscopic sleeve gastrectomy procedure, the liver retractor broke and the pt's liver sustained a very small laceration, possibly due to a metal piece that was protruding from the broken retractor after it broke.The laceration resulted in some bleeding and was handled by cauterization.Pt recovered without incident.

Manufacturer Narrative

We evaluated the instrument and found that the linkage is broken near the distal end.One side of the broken linkage moves/protrudes outside the linkage channel, although it is still attached.We have no other complaints for this item reporting the same issue of breakage of linkage, and although we cannot confirm cause of the breakage, we suspect it may be due to either being mishandled/dropped or possible mechanical overload.

• Brand Name: CUSHIERI LIVER RETRACTOR
• Type of Device: LIVER RETRACTOR
• Manufacturer (Section D): KARL STORZ GMBH & CO; tuttlingen ; GM
• Manufacturer (Section G): KARL STORZ GMBH & CO. KG; mittelstrasse 8; tuttlingen, de 7850 3
• Manufacturer Contact: susie chen ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 4782217
• MDR Text Key: 5802882
• Report Number: 9610617-2015-00033
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 30623U
• Device Catalogue Number: 30623U
• Device Lot Number: PV02
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/20/2015
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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 Age: 47 YR