MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 6.5MM CANNULA, 2 ROTATING STOPCOCKS; ACCESSORIES,ARTHROSCOPIC

Catalog Number 0377031650

Device Problems Detachment Of Device Component (1104); Material Disintegration (1177); Material Twisted/Bent (2981); Positioning Problem (3009)

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

Event Date 03/26/2014

Event Type  malfunction  

Event Description

It was reported that the seal/gasket is falling out when in use.It was further stated that the unit becomes unseated, twisted, and disintegrates.A replacement unit was available.

Manufacturer Narrative

The product was not returned for investigation.Therefore, the reported failure mode could not be confirmed.The possible root cause for the failure can be due to: 1) improper sterilization methods 2) handling error.However, this cannot be confirmed since the unit was not returned.In the event that the unit is returned, a full evaluation will be conducted and a follow up report will be issued.

Event Description

It was reported that the seal/gasket is falling out when in use.It was further stated that the unit becomes unseated, twisted, and disintegrates.A replacement unit was available.

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

• Brand Name: 6.5MM CANNULA, 2 ROTATING STOPCOCKS
• 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: thomas shafer ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 3771664
• MDR Text Key: 4729460
• Report Number: 0002936485-2014-00264
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2014

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: Health Professional
• Device Catalogue Number: 0377031650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2014
• Initial Date FDA Received: 04/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/27/2014
• 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