MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE UNKNOWN_ENDOSCOPY_PRODUCT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number UNK_END

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

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

Event Date 04/20/2022

Event Type  Injury  

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.The part number is not known at this time, therefore the gtin and 510 is not known.However, should it become available it will be provided in future reports.

Event Description

It was reported that the patient was burned.It was unable to be confirmed which device caused the burn.

Manufacturer Narrative

The reported device was not received for investigation; therefore the reported failure cannot be confirmed.The complaint will be closed without a detailed investigation.In the event that the device is received, the complaint will be reopened and the investigation will be updated with the new results.Probable root cause: heat can result from insufficient suction which can result from: inadequate hospital suction, leak, bad connection to hospital suction line, clogging caused by suction path blockage, lower electrode mass due to variation in electrode thickness or opening cut.Use error.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.

Event Description

It was reported that the patient was burned.It was unable to be confirmed which device caused the burn.

• Brand Name: UNKNOWN_ENDOSCOPY_PRODUCT
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 14434163
• MDR Text Key: 292022967
• Report Number: 0002936485-2022-00251
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• 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: 06/17/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_END
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 05/19/2022
• Supplement Dates Manufacturer Received: 04/20/2022
• Supplement Dates FDA Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other