MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LT GUIDE,GEMINI,5MM X 10FT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number 7205178

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/24/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

During a hysteroscopy procedure it was reported that the tip was inserted into the light source and within 30 seconds a burning odor was noticed.The odor was traced to the light cable and we pulled it out; the tip of the light cable was smoking and burning.No other apparent damage was noticed.The procedure was able to be successfully completed with a backup device of the same type.The patient was fine post-procedure and there were no complications.

Manufacturer Narrative

Visual inspection of the device showed the light guide had been in use for some time.The light source surface end of the light guide is melted making evaluation difficult.Due to the condition and severity of the melting a root cause cannot be determined with confidence.The most possible cause is that there may have been residue that was not removed on the glass fibers and caused it to burn when attached to a light source.No manufacturing related defects were observed during the evaluation.Review of the device history records further found there were no inconsistencies during manufacturing.

• Brand Name: LT GUIDE,GEMINI,5MM X 10FT
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5163944
• MDR Text Key: 29067482
• Report Number: 3003604053-2015-00098
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K914919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7205178
• Device Lot Number: 115580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2015
• 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 Age: 32 YR
• Patient Weight: 64