MAUDE Adverse Event Report: STRYKER SPINE-FRANCE LIGHT CABLE; SURGICAL LAMP

Catalog Number	48089999
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/16/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; smell was coming out of light source.We switched to new a source.Notice end of light cable was charred.When we switched light units the smell dissipated.Few min later, surgeon pulled out light cable from light decompression tube immediately.Said it sparked.Update (18-apr-2016): surgeon said he saw a spark inside tube which was in patient.Used replacement.
Additional Manufacturer Narrative
Visual inspection; functional inspection; device history review; complaint history review; risk assessment; no manufacturing issues were discovered.All units were designed according to stryker specifications.The most likely cause of the reported event is the light cable being attached to a non-compatible light source.This would result in the charring present on the light cable, as well as the odor eminating from the light source.The surgical technique states that "light cable must be used with a light source that has been tested to iec safety standards, and is compatible with an acmi connection." the most likely cause of the reported event is the light cable being attached to a non-compatible light source.However, this cannot be confirmed.
Event or Problem Description
It was reported that; smell was coming out of light source.We switched to new a source.Notice end of light cable was charred.When we switched light units the smell dissipated.Few min later, surgeon pulled out light cable from light decompression tube immediately.Said it sparked.Update (b)(6) 2016: surgeon said he saw a spark inside tube which was in patient.Used replacement.

• Brand Name: LIGHT CABLE
• Common Device Name: SURGICAL LAMP
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5645359
• Report Number: 0009617544-2016-00177
• Device Sequence Number: 13466287
• Product Code: FST
• UDI-Device Identifier: 07613327064926
• UDI-Public: (01)07613327064926
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122637
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2016

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
• Operator of Device: No Information
• Device Catalogue Number: 48089999
• Device Lot Number: 154098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2016
• Supplement Report FDA Received Date: 07/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1