MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY HALSEY NEEDLE HOLDER

Model Number 516012

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2016

Event Type  malfunction  

Manufacturer Narrative

Device not returned.

Event Description

Allegedly, while doctor was performing a rhinoplasty, one jaw of the instrument broke off into patient.The doctor immediately removed the broken piece; the instrument was replaced and the procedure was completed with no delay.The hospital reported there was no serious injury to the patient.

Manufacturer Narrative

Instrument was evaluated and it was confirmed that a small piece on the end of one jaw had broken off.Possible cause is stress overload, but we cannot confirm.

Event Description

This is a supplemental report to add evaluation of instrument.Will enter evaluation and update related fields.Corrected with correct lot code.Corrected with correct device manufacturer date.

• Brand Name: HALSEY NEEDLE HOLDER
• Type of Device: NEEDLE HOLDER
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• Manufacturer (Section G): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 6084227
• MDR Text Key: 59345807
• Report Number: 9610617-2016-00165
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2016

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: Physician
• Device Model Number: 516012
• Device Catalogue Number: 516012
• Device Lot Number: PU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 11/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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