MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 1188HD CAMERA HEAD; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	1188210105
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Alleged failure: poor image.The failure(s) identified in the investigation is consistent with the complaint record.Root cause: the most likely root cause of this issue could be wear and tear since this camera head has been on the field for over eight years and the cable for two and repeated sterilizations may result in degradation of the unit.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the image was dark.The procedure was completed successfully.

• Brand Name: PKG, 1188HD 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: 9077839
• Report Number: 0002936485-2019-00399
• Device Sequence Number: 16765684
• Product Code: GCJ
• UDI-Device Identifier: 07613327063332
• UDI-Public: 07613327063332
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142603
• 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
• Report Date (Section B): 09/17/2019

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: 1188210105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1