MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PINPOINT LIGHT CABLE; LAPAROSCOPE, GENERAL & PLASTIC

Catalog Number	PC9004
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mfg date: the device manufacture date is not known at this time.However, should it become available, it will be provided in future reports.Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that there was a thermal event.
Additional Manufacturer Narrative
The product was not returned for investigation and the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: customer reported flames between the light lead and scope light post attachment during use.Probable root cause: the reported failure mode is consistent with previous failures in which there was residue left over from sterilization between the laparoscope and light guide connection points.This residue burned up and created smoke, leading to darkening and loss of image.Manufacture date is not known.H3 other text : 81.
Event or Problem Description
It was reported that there was a thermal event.

• Brand Name: PINPOINT LIGHT CABLE
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; burnaby; san jose CA 95138
• MDR Report Key: 8165773
• Report Number: 3012345110-2018-00017
• Device Sequence Number: 11127589
• Product Code: GCJ
• UDI-Device Identifier: 00858701006568
• UDI-Public: 00858701006568
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K150956
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2019

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: Health Professional
• Device Catalogue Number: PC9004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1