MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PINPOINT LAPAROSCOPE - 10MM, STANDARD, 30 WITH WOLF AND STORZ ADAPTOR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	SC9134
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/05/2018
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 laparoscope was delivering a foggy image during a medical procedure.A replacement device was used to "completed" the procedure.
Event or Problem Description
It was reported that the laparoscope was delivering a foggy image during a medical procedure.A replacement device was used to completed the procedure.
Additional Manufacturer Narrative
The device was returned for investigation and the reported failure mode was confirmed.Alleged failure: "foggy image.There might be a moisture inside the scope." probable root cause: as per manufacturer, the malfunction was most likely caused by a wrong or too strong reprocessing method of this endoscope by the customer (i.E.Aggressive disinfectant).The reported failure mode will be monitored for future reoccurrence.The device manufacture date is not known.

• Brand Name: PINPOINT LAPAROSCOPE - 10MM, STANDARD, 30 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: 8072071
• Report Number: 3012345110-2018-00015
• Device Sequence Number: 10816886
• 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: 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: SC9134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 11/14/2018
• 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