MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG COLORADO NEEDLE, 3 CM STRAIGHT (3/32") SLEEVE; INSTRUMENT

Catalog Number	N103A
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	10/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Event or Problem Description
It was reported that during an ophthalmology case to repair ptosis of the left upper eyelid, a spark and fire was noted to come from the cautery pencil at the junction where the cautery needle connects into the cautery pencil.Wet gauze was immediately placed over the eye which extinguished the fire.The fire burned the patient's eyelashes, but no skin or other areas were burned.The staff and physician were unharmed.Supplemental oxygen was not being used.
Additional Manufacturer Narrative
Correction: the device under complaint has not been returned as was initially reported; therefore, the reported event could not be confirmed.To obtain more details about the complained event and for an immediate product return shipment, the sales rep was contacted.Unfortunately, the device has not been returned after several attempts.The provided information was reviewed but it was not possible to determine the root cause for the reported failure.According to the supplier in cork, ireland the insulation integrity is proven in each lot.Testing completed in nov 2004 ref tr l1698.041573 has indicated that a needle product may ignite only if it is physically ignited with a flame, or if it is touched with the electrode pad.Sparking may have occurred on the product if excess tissue debris was not removed from the product.All relevant quality documents (inspection documents) have been reviewed.The device history record for article# n103a and lot/batch code# 18199017 indicates (b)(4) were manufactured on 2018-oct-10 and accepted into final stock.No issues could be found in the manufacturing or inspection documents.Based on the statistical investigation there is no indication for an incorrectly working product or any systematic design, material or manufacturing related issue.Therefore, no further corrective and / or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.
Event or Problem Description
It was reported that during an ophthalmology case to repair ptosis of the left upper eyelid, a spark and fire was noted to come from the cautery pencil at the junction where the cautery needle connects into the cautery pencil.Wet guaze was immediately placed over the eye which extinguished the fire.The fire burned the patient's eyelashes, but no skin or other areas were burned.The staff and physician were unharmed.Supplemental oxygen was not being used.

• Brand Name: COLORADO NEEDLE, 3 CM STRAIGHT (3/32") SLEEVE
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 8118354
• Report Number: 0008010177-2018-00111
• Device Sequence Number: 202503
• Product Code: GEI
• UDI-Device Identifier: 04546540004093
• UDI-Public: 04546540004093
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: N103A
• Device Lot Number: 1819017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other