MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG KOH ULTRAMICRO INJECTION NEEDLE

Model Number 26176NA

Device Problems Fracture (1260); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2014

Event Type  malfunction  

Event Description

Allegedly, during a laparoscopic cystectomy, when the doctor attempted to go into the cyst with the needle, the needle bent and broke off into the patient's abdomen without penetrating the cyst.The broken piece was immediately retrieved and another instrument was used for the procedure.The procedure was completed with no patient impact.

Manufacturer Narrative

This instrument was evaluated and we confirmed the distal end of the injection needle is broken off and is missing.Customer reported that the needle never penetrated the cyst.We believe it is possible the cyst had calcified, causing the needle to break when the doctor attempted to penetrate the cyst.The instrument had been in use for approximately 4 months.We show no defect trend; this is the only report we have for this product/issue.

• Brand Name: KOH ULTRAMICRO INJECTION NEEDLE
• Type of Device: INJECTION NEEDLE
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG; mittelstrasse 8; tuttlingen ; GM
• Manufacturer (Section G): KARL STORZ GMBH & CO. KG; mittelstrasse 8; tuttlingen 7850 3; GM 78503
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 3881739
• MDR Text Key: 4542165
• Report Number: 9610617-2014-00022
• Device Sequence Number: 1
• Product Code: HET
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950962
• 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: 04/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26176NA
• Device Catalogue Number: 26176NA
• Device Lot Number: XX01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/08/2014
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• 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