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 Thermal Decomposition of Device (1071)

Patient Problem No Information (3190)

Event Date 10/17/2017

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

An event description of "burned" was reported.It is unclear as to whether a patient or user was burned, or if there was a problem with the product.Several attempts were made to obtain additional information, however, no response was received.

Manufacturer Narrative

Alleged failure: burned.Confirmed failure: outer tube damaged (bent, dented),moisture ingression at distal end.Probable root cause: too much light from light source.Light source left on and scope/adapter left on or in patient.Reflected laser energy to the scope when used with laser equipment.Electrical discharge or coupled hf current when used with hf surgical equipment.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.(b)(4).The device manufacturer date is not known.

Event Description

An event description of "burned" was reported.It is unclear as to whether a patient or user was burned, or if there was a problem with the product.Several attempts were made to obtain additional information, however, no response was received.

• 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: valerie estrada ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 7031640
• MDR Text Key: 92022395
• Report Number: 0002936485-2017-01104
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0502904030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2017
• 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