MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., 4MM AUTOCLAVABLE ARTHROSCOPE

Catalog Number 0502477031

Device Problem Component Falling (1105)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/14/2017

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 a chip from the scope fell inside the patient.

Manufacturer Narrative

Gtin:(b)(4).The device manufacture date is not known.Alleged failure: chipped.Confirmed failure: outer tube damaged (bent, dented).Probable root cause: contact with shaver, rf probe or other instrument.The product was returned for investigation and the failure mode was confirmed and will be monitored for future reoccurrence.

Event Description

It was reported a chip from the scope fell inside the patient.

• Brand Name: PKG., 4MM AUTOCLAVABLE ARTHROSCOPE
• 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: valerie estrada ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 6711113
• MDR Text Key: 79955645
• Report Number: 0002936485-2017-00674
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962075
• 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: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0502477031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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