MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, PRECISION HD 30 DEG., ARTHROSCOPE, 4.0MM X 140MM, C-MOUNT, SPEEDLOCK, A/C

Catalog Number 0502904030

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 05/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.

Event Description

It was reported the device contributed to patient infection.

Manufacturer Narrative

Scope was sent in as a repair with only please evaluate no complaint attached.Scope was decontaminated, evaluated and sent out prior to notification that a bacterial testing should done as there have been 3 patient infections tied back to this specific serial number at the acct, thus the reported failure was not confirmed.Alleged failure: 3 patient infections tied back to this specific serial number at the acct.Confirmed failure: outer tube damaged (bent, dented).Probable root cause: improper storage conditions, improper handling, sterilization process not effective, improper reprocessing.The device manufacturer date is not known.The product was returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.(b)(4).

Event Description

It was reported the device contributed to patient infection.

• Brand Name: PKG, PRECISION HD 30 DEG., ARTHROSCOPE, 4.0MM X 140MM, C-MOUNT, SPEEDLOCK, A/C
• Type of Device: ARTHROSCOPE
• 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: sandhya jaishankar ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 6710952
• MDR Text Key: 79951192
• Report Number: 0002936485-2017-00671
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0502904030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/02/2017
• Initial Date FDA Received: 07/13/2017
• Supplement Dates Manufacturer Received: 05/02/2017
• Supplement Dates FDA Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other