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

Catalog Number	1188210105
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/18/2019
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 the procedure was converted to an open procedure.
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: the image of the camera was very dark during the surgery.Probable root cause: - cables - connectors - digital board - main board - transition board - software - camera head - coupler - connected monitors - manufacturing/ service nonconformity - use error.The failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the procedure was converted to an open procedure.

• 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: 8786207
• Report Number: 0002936485-2019-00293
• Device Sequence Number: 2038809
• Product Code: GCJ
• UDI-Device Identifier: 07613327063332
• UDI-Public: 07613327063332
• Combination Product (Y/N): N
• PMA/510(K) Number: K142603
• 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): 09/18/2019

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: 1188210105
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 09/18/2019
• 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