MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE SERFAS 50-S SWEEP + XL; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 0279351653

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/17/2022

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.

Event Description

It was reported that the tip of the device broke and was unable to be removed from the patient.

Event Description

It was reported that the tip of the device broke and was unable to be removed from the patient.

Manufacturer Narrative

The device manufacturer date is not known.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: distal tip broke off.Probable root cause: non-conforming component, poor assembly process, misuse.Use error.The reported failure mode will be monitored for future reoccurrence.

• Brand Name: SERFAS 50-S SWEEP + XL
• 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: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15784655
• MDR Text Key: 303540620
• Report Number: 0002936485-2022-00652
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 07613327405828
• UDI-Public: 07613327405828
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K171391
• 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

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0279351653
• Device Catalogue Number: 0279351653
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2022
• 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