MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 22 FR, COLLINGS KNIFE ELECTRODE; CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Catalog Number 0504990800

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2018

Event Type  malfunction  

Manufacturer Narrative

The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.

Event Description

It was reported that there was a breach in the sterile barrier.

Manufacturer Narrative

The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Through the investigation it was confirmed that rust was not found on the devices inside the sterile packaging, therefore making this event not reportable.Updated rationale from malfunction to no report required.Manufacture date is not known.Alleged failure: the rusty electrodes can be clearly seen before opening the package.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be user dissatisfaction.

Event Description

Per investigation results, it is confirmed that rust was not found on the device in the sterile packaging.Therefore making this event not reportable.

• Brand Name: PKG, 22 FR, COLLINGS KNIFE ELECTRODE
• Type of Device: CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8165772
• MDR Text Key: 130623469
• Report Number: 0002936485-2018-00719
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 37613327055598
• UDI-Public: 37613327055598
• Combination Product (y/n): N
• PMA/PMN Number: K040390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

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: Other
• Device Catalogue Number: 0504990800
• Device Lot Number: STRKN01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Initial Date Manufacturer Received: 11/25/2018
• Initial Date FDA Received: 12/14/2018
• Supplement Dates Manufacturer Received: 11/25/2018
• Supplement Dates FDA Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1