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 Code Available (3191)
Date of Event	08/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the scope showed poor image resulting in conversion to open procedure.The procedure was completed successfully.
Event or Problem Description
It was reported that the scope showed poor image resulting in conversion to open procedure.The procedure was completed successfully.
Additional Manufacturer Narrative
Alleged failure: "a laparoscopic procedure had to be stopped because the screen of the novadq tower became illegible.The screen got a coarse-grained output." probable root cause: given that the reported image quality issues could not be reproduced, it is believed the root cause is likely due to another component of or use of the entire system.The three following possibilities are believed to have potentially caused the reported ¿coarse, grained output¿.1.A long press of the 1 button on the camera will turn off both vis and nir light, resulting in no image or a very dark image, as illumination has been removed.Should the user not realize this, they may think the scope has malfunctioned.2.As seen in a previous photo, spy mode can look very coarse and grainy when there is excessive noise ¿ if another light source was used endoscopically, this could cause enough interference for the spy image to appear coarse and grainy 3.In a similar vein, not understanding icg injection best practices could lead to an instance in which insufficient fluorescence was misinterpreted as an image quality issue the device was returned for investigation and the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.

• 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; san jose CA 95138
• MDR Report Key: 7907944
• Report Number: 3012345110-2018-00010
• Device Sequence Number: 1914307
• 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: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 10/08/2018
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other