MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE STICK, CANNULATED REUSEABLE; ACCESSORIES,ARTHROSCOPIC

Catalog Number CAT01515

Device Problem Malposition of Device (2616)

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

Event Date 08/30/2017

Event Type  malfunction  

Manufacturer Narrative

Alleged failure: bio-burden on sticks.Probable root cause: design.Confusing/incomplete reprocessing instructions provided with the device.Device design not able to be cleaned/disinfected (weight, lumen design, difficult to penetrate features, etc).Product is not able to be cleaned/ disinfected at the end of its projected lifetime.Application: instrument is not quickly reprocessed; soil dries and becomes difficult to remove.Improper cleaning agents used.Cleaning agents (ie detergents) prepared improperly.Improper maintenance of user facilities/utilities: user does not follow provided reprocessing instructions.The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Gtin: (b)(4).Lot number is unknown; therefore, manufacture date can not be confirmed.

Event Description

It was reported that the cannulated switching stick was found with bio-burden inside which could potentially lead to infection.

• Brand Name: STICK, CANNULATED REUSEABLE
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• 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: ashley lower ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 7010155
• MDR Text Key: 92548230
• Report Number: 0002936485-2017-01064
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/08/2017

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: CAT01515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/11/2017
• Initial Date FDA Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1