MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG 1288HD CAMERA HEAD; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	1288210105
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Output Problem (3005); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/27/2019
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 there were image issues which led to conversion to open procedure.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.The reported failure mode will be monitored for future reoccurrence.Alleged failure: fading of image probable root cause: cables connectors digital board power supply filter / fuse ac inlet board main board transition board fiber board intermittence between transition board and ch connector fan / insufficient cooling software camera head coupler extension cable intermittence while using rf devices problem toggling light source from camera head connected monitors leaking manufacturing/ service nonconformity use error.
Event or Problem Description
It was reported that there were image issues which led to conversion to open procedure.
Additional Manufacturer Narrative
The device was received at the local service facility for investigation.The technical service report is attached (see communication log), and indicates: "device conforms to specification and passed all test results during final inspection" probable root cause: cables, connectors, digital board, power supply, filter / fuse, ac inlet board, main board, transition board, fiber board, intermittence between transition board and ch connector, fan / insufficient cooling, software, camera head (sensor, sensor cable), coupler (dust on optics, scratched optics, broken / shifted lenses, focusing mechanism, endoclamp), extension cable, intermittence while using rf devices (ex: valleylab), problem toggling light source from camera head, connected monitors, leaking, manufacturing/ service nonconformity, use error.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there were image issues which led to conversion to open procedure.

• Brand Name: PKG 1288HD CAMERA HEAD
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9476934
• Report Number: 0002936485-2019-00569
• Device Sequence Number: 16722683
• Product Code: GCJ
• UDI-Device Identifier: 07613327063424
• UDI-Public: 07613327063424
• Combination Product (Y/N): N
• PMA/510(K) Number: K132785
• 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,Followup
• Report Date (Section B): 08/04/2020

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 Model Number: 1288210105
• Device Catalogue Number: 1288210105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 11/27/2019; 11/27/2019
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 02/26/2020; 08/04/2020
• 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
• Patient Age: 79 YR
• Patient Weight: 74