MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 1488 HD 3-CHIP CAMERA HEAD, C-MOUNT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	1488210105
Medical Device Problem Codes	Gas/Air Leak (2946); Excessive Heating (4030)
Health Effect - Clinical Codes	Superficial (First Degree) Burn (2685); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Serious Injury
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 the user was burned.
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: visual inspection: there was no visual damage or change recorded on the device.Functional inspection: there was no functional loss or change recorded on the device.Dimensional inspection: there was no dimensional change recorded on the device.Expanded investigation activities: the device was tested for all functionality, no damage or functionality loss was detected.Confirmation: the customer complaint could not be replicated investigation conclusion: right after the customer complaint, device was investigated at customer site.Any failure, error or break down status were not detected.Device was subjected to general functionality tests, and everything was recorded normal.Probable root cause: camera head design.Use error.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that the user was burned.

• Brand Name: PKG, 1488 HD 3-CHIP CAMERA HEAD, C-MOUNT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11737213
• Report Number: 0002936485-2021-00228
• Device Sequence Number: 17041892
• Product Code: GCJ
• UDI-Device Identifier: 07613327061055
• UDI-Public: 07613327061055
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K132785
• 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): 06/08/2021

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: 1488210105
• Device Catalogue Number: 1488210105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 06/08/2021
• 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