MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 5MM PEEK HANDLE, 45CM; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Model Number 0250181164

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Temperature Problem (3022)

Patient Problems Superficial (First Degree) Burn (2685); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2022

Event Type  malfunction  

Event Description

It was reported that there was patient burn.

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.

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: patient burn probable root cause: heat conducted by device (excessive rf energy, etc.) use error insulation damage or inadequate insulation from manufacturing/ servicing the reported failure mode will be monitored for future reoccurrence manufacture date is not known.H3 other text : 81.

Event Description

It was reported that there was patient burn.

• Brand Name: PKG, 5MM PEEK HANDLE, 45CM
• Type of Device: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15988906
• MDR Text Key: 305540057
• Report Number: 0002936485-2022-00756
• Device Sequence Number: 1
• Product Code: OCZ
• UDI-Device Identifier: 07613327056716
• UDI-Public: 07613327056716
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0250181164
• Device Catalogue Number: 0250181164
• Device Lot Number: 2040218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other