MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE HD 4MM X 30A ARTHROSCOPE SPEEDLOCK A/C

Model Number 0502104030

Device Problems Break (1069); Optical Problem (3001)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/28/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that fragments was left inside the patient.

Event Description

It was reported that fragments was left inside the patient.

Manufacturer Narrative

The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.  alleged failure: lost clarity of vision throughout case.Probable root cause: incorrectly assembled optical train.Damage to optical train.Debris in optical train.End of life wear-out.Shipping damage.Use error.Manufacture date is not known.H3 other text : 81.

• Brand Name: HD 4MM X 30A ARTHROSCOPE SPEEDLOCK A/C
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10081220
• MDR Text Key: 191793760
• Report Number: 0002936485-2020-00205
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07613327062113
• UDI-Public: 07613327062113
• Combination Product (y/n): N
• PMA/PMN Number: K962075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0502104030
• Device Catalogue Number: 0502104030
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other