MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 5FR. BUGBEE ELECTRODE, 65CM; CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Catalog Number 0504860065

Device Problem Break (1069)

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

Event Date 08/02/2021

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 broke during procedure.The broken tip was successfully retrieved.

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.The reported failure mode will be monitored for future reoccurrence.Alleged failure: tip broke off.Probable root cause: 1.Manufacturing/assembly error 2.Severe shipping conditions 3.Material/design error 4.Constant irrigation flow is not maintained leading to limited field of view 5.Low lubricity of insulation for fulgurating electrodes 6.Use error manufacture date is not known.H3 other text : 81.

Event Description

It was reported that the tip broke during procedure.The broken tip was successfully retrieved.

• Brand Name: PKG, 5FR. BUGBEE ELECTRODE, 65CM
• Type of Device: CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• 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: 12385860
• MDR Text Key: 270314811
• Report Number: 0002936485-2021-00474
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 37613327055345
• UDI-Public: 37613327055345
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040390
• 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: 12/07/2022

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: 0504860065
• Device Lot Number: STENCE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 08/30/2021
• Supplement Dates Manufacturer Received: 08/03/2021
• Supplement Dates FDA Received: 12/07/2022
• 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