MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PINPOINT LAPAROSCOPE - 10MM, STANDARD, 0 WITH WOLF AND STORZ ADAPTOR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	SC9104
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2018
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 the scope showed a potentially decreased image output to an unknown level.The procedure was completed successfully with no medical intervention or surgical delay.
Additional Manufacturer Narrative
The device was returned for investigation and the reported failure mode was confirmed.Alleged failure: "item is defective.Optic is cloudy." probable root cause: as per manufacturer, the malfunction was most likely caused by normal use, customer use and/or handling.The device manufacture date is not known.The reported failure mode will be monitored for future re-occurrence.
Event or Problem Description
It was reported that the scope showed a potentially decreased image output to an unknown level.The procedure was completed successfully with no medical intervention or surgical delay.

• Brand Name: PINPOINT LAPAROSCOPE - 10MM, STANDARD, 0 WITH WOLF AND STORZ ADAPTOR
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; burnaby; san jose CA 95138
• MDR Report Key: 7923317
• Report Number: 3012345110-2018-00011
• Device Sequence Number: 13966167
• Product Code: GCJ
• UDI-Device Identifier: 00858701006063
• UDI-Public: 00858701006063
• Combination Product (Y/N): N
• 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): 03/22/2019

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: SC9104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Initial Date Received by Manufacturer: 09/01/2018
• Supplement Date Received by Manufacturer: 09/01/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1