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

Model Number 0250181106

Device Problems Arcing (2583); Temperature Problem (3022)

Patient Problems Burn(s) (1757); Superficial (First Degree) Burn (2685)

Event Date 04/25/2023

Event Type  malfunction  

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 Description

It was reported that the patient was burned.It was confirmed that it was minor and did not need medical intervention.

Event Description

It was reported that the patient was burned.It was confirmed that it was minor and did not need medical intervention.

Manufacturer Narrative

Alleged failure: this customer experienced an electrical arching on a lap instrument that burned the patient.The information on the equipment is below.They would like an assessment done on both pieces to understand how it happened.They are not interested in repairing/replacing these items at this time.How can we set this up? salesforce case number (b)(4).The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be third party repair and/or multiple usage including sterilization causing the insulation to degrade.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• Brand Name: PKG, 5MM MULTI-FUNCTION PEEK HANDLE
• 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: 16969413
• MDR Text Key: 315776779
• Report Number: 0002936485-2023-00489
• Device Sequence Number: 1
• Product Code: OCZ
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0250181106
• Device Catalogue Number: 0250181106
• Device Lot Number: 1543707K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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