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 Material Opacification (1426)

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

Event Date 06/17/2019

Event Type  malfunction  

Manufacturer Narrative

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 scope was blurry during procedure, a replacement was used and procedure was completed successfully.

Event Description

It was reported scope was blurry during procedure, a replacement was used and procedure was completed successfully.

Manufacturer Narrative

Alleged failure:blurry.Confirmed failure: outer tube damaged (bent, dented),damaged distal cover glass.Probable root cause: ¿ incorrectly assembled optical train ¿ damage to optical train ¿ end of life wear-out ¿ shipping damage ¿ use error the product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.

• 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
• MDR Report Key: 8776195
• MDR Text Key: 150747352
• Report Number: 0002936485-2019-00286
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07613327063844
• UDI-Public: 07613327063844
• Combination Product (y/n): N
• PMA/PMN Number: K093677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: No
• 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: 06/26/2019
• Date Manufacturer Received: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1