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

Model Number	PC9002
Medical Device Problem Codes	No Display/Image (1183); Electrical Shorting (2926)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that there was image loss & thermal event during procedure.Please note that the procedure was completed successfully with no reports of adverse consequences.
Additional Manufacturer Narrative
Alleged failure: during the thoracoscopic surgery, the control unit skipped and the camera stopped working.See photos attached with the burnt connector.The surgery was delayed for 20 minutes, as the entire column had to be changed probable root cause: the observed cable connector pin damage was a known issue with older generation camera cables.The issue was caused by epoxy escaping the connector and bulging underneath the connector pins after reprocessing, resulting in an upward bend.The issue has been addressed in the current connector redesign by addition of an epoxy dam as well as changing the epoxy to a more durable compound which does not bulge from reprocessing.The device was returned for investigation and the reported failure mode was confirmed.The reported failure mode will be monitored for future re occurrence.Manufacture date is not known.
Event or Problem Description
It was reported that there was image loss & thermal event during procedure.Please note that the procedure was completed successfully with no reports of adverse consequences.

• Brand Name: PINPOINT CAMERA HEAD
• 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: 10307922
• Report Number: 3012345110-2020-00003
• Device Sequence Number: 3484919
• Product Code: GCJ
• UDI-Device Identifier: 00858701006551
• UDI-Public: 00858701006551
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 09/09/2020

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 Model Number: PC9002
• Device Catalogue Number: PC9002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1