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

Model Number	PC9002
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Death (1802); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that there was patient death.Please note that there is no alleged deficiency with the reported devices and it cannot be determined at this time, which, if any, of the reported devices may have caused or contributed to patient outcome.
Event or Problem Description
It was reported that there was patient death.Please note that there is no alleged deficiency with the reported devices and it cannot be determined at this time, which, if any, of the reported devices may have caused or contributed to patient outcome.
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.Alleged failure: "none of the products are defective/faulty or were involved at the time of death.Patient died during open colon interposition surgery.Products were placed in the thorax only to illuminate.During the surgery, the light guide cable, lens and camera were used to illuminate deeper into the patient's open thorax (to help the doctors see better).The devices are demo goods from our sales rep.Our sales rep was present during the surgery." probable root cause: according the the customer provided event description, no failure or malfunction was associated with the pinpoint system.The patient death which occurred during the case was a separate issue not related to any of the pinpoint devices.The reported failure mode will be monitored for future reoccurrence.The device manufacture date is not known.H3 other text : 81.

• 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: 10532262
• Report Number: 3012345110-2020-00005
• Device Sequence Number: 13770504
• Product Code: GCJ
• UDI-Device Identifier: 00858701006551
• UDI-Public: 00858701006551
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/28/2020

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: PC9002
• Device Catalogue Number: PC9002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 10/28/2020
• 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: Death
• Patient Age: 60 YR