MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 90-S XL; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	0279351103
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the residual glue broke off during surgery.All pieces were retrieved and the procedure was completed successfully.
Additional Manufacturer Narrative
Alleged failure: the bead (at the white ceramic sleeve around the ablation sheet) loosened.Bead could be completely removed.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be during assembly the cleaning and the wiping instruction of the excess glue after applying was not performed.An excess force applied to the probe will contribute to the excess glue detachment, and protective measure such as in-process inspections.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the residual glue broke off during surgery.All pieces were retrieved and the procedure was completed successfully.

• Brand Name: 90-S XL
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 7550887
• Report Number: 0002936485-2018-00464
• Device Sequence Number: 11059585
• Product Code: GEI
• UDI-Device Identifier: 07613327056976
• UDI-Public: 07613327056976
• Combination Product (Y/N): N
• PMA/510(K) Number: K071859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2018

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: Health Professional
• Device Catalogue Number: 0279351103
• Device Lot Number: 17350AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1