MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA; ACCESSORIES, ARTHROSCOPIC

Catalog Number 3910090800

Device Problems Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Extravasation (1842); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient experienced extravasation.

Manufacturer Narrative

This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.The reported failure mode will be monitored for future reoccurrence.Alleged failure: serum continuous leakage probable root cause: incorrect size/configuration of seal seal improperly placed improperly welded lid misaligned h3 other text : 81.

Event Description

It was reported that the patient experienced extravasation.

• Brand Name: ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA
• 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: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 12578302
• MDR Text Key: 274817512
• Report Number: 0002936485-2021-00529
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 37613327055796
• UDI-Public: 37613327055796
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3910090800
• Device Lot Number: 20298AG2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2020
• 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
• Patient Sex: Male