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

Catalog Number UNK_END

Device Problems Continuous Firing (1123); Device Remains Activated (1525)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2022

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.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 device was continuously activating.

Event Description

It was reported that the device was continuously activating.

Manufacturer Narrative

The product was not returned for investigation and the reported failure mode was not confirmed.Alleged failure: serfas wand is activating by itself.Probable root cause: probe short, button stuck on firing position, fluid ingress, suction tube cut, button inadvertently pressed, damaged insulation, probe bender used to bend nonbendable probe, user accidentally submerges device, inadequate gluing operations (tip and core/lumen) or inadequate gluing/welding of core to handle console error: refer to rsk10684 for risk outputs associated with rf energy to probe for the serfas energy console.Refer to (b)(4) for risk outputs associated with rf signal to handpiece for crossfire and crossfire ii consoles use error.Lot number is unknown; therefore, manufacture date can not be confirmed.The failure mode will be monitored for future reoccurrence.

• 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: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15709356
• MDR Text Key: 306911750
• Report Number: 0002936485-2022-00630
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_END
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2022
• Initial Date FDA Received: 11/01/2022
• Supplement Dates Manufacturer Received: 10/12/2022
• Supplement Dates FDA Received: 01/17/2023
• 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