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

Catalog Number 0279351103

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Code Available (3191)

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.Gtin: (b)(4).

Event Description

It was reported that the tip broke and could not be found.

Manufacturer Narrative

Alleged failure: small white part of the plastic ring at the top of probe loosened the failure identified in the investigation is consistent with the complaint record.Although, there was no physical evidence of the alleged claim, based on the reported condition.A possibility the material seen by the customer on the probe was the excess glue on top of the ceramic and potentially breaking off during use.The probable root cause/s could be the cleaning/wiping off the excess glue after applying was not performed during assembly.An excess force applied to the probe will contribute to the excess glue detachment.Since the excess glue condition was confirmed to be a result of the manufacturing related issue.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.(b)(4).

Event Description

It was reported that the tip broke and could not be found.

• Brand Name: 90-S 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: valerie estrada ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 7435383
• MDR Text Key: 105635119
• Report Number: 0002936485-2018-00344
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K071859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0279351103
• Device Lot Number: 17350AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2017
• 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