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

Catalog Number	PC9004
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that there was a thermal event.
Additional Manufacturer Narrative
Alleged failure: "it was reported by the sales rep (b)(6) during a case the light adaptor guide got hot.Got a different light guide and within 4-5 minutes it got hot.The image was getting interference as well." probable root cause: burnaby qe confirmed with sales representative that failure was caused by an older generation (single fused) light guide cable.The output end was visibly blackened, causing excess heat at the laparoscope connection point which in turn leads to diminishing image quality.The reported failure mode is caused by leftover debris and residue at the scope/light guide junction from insufficient/improper cleaning post sterilization and reprocessing.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.The device manufacturer date is not known.

• Brand Name: PINPOINT LIGHT CABLE
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8322842
• Report Number: 3012345110-2019-00001
• Device Sequence Number: 1663679
• Product Code: GCJ
• UDI-Device Identifier: 00858701006568
• UDI-Public: 00858701006568
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K150956
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2019

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1