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

Catalog Number	0504990800
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that there was a breach in the sterile barrier.
Additional 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 or Problem 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
• Common Device Name: COPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 7991484
• Report Number: 0002936485-2018-00657
• Device Sequence Number: 11183086
• Product Code: FAJ
• UDI-Device Identifier: 37613327055598
• UDI-Public: 37613327055598
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K040390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1