MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PRECISION IE 4K EYEPIECE ARTHROSCOPE, AUTOCLAVABLE, 4MM X 30, 140MM, SPEED-LOCK

Model Number 0502-444-030

Device Problem Optical Problem (3001)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer 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 there was loss of image.

Manufacturer Narrative

Alleged failure: mélanie ravon (customer) sent a request for replacing the device: " in pj, new exchange request for an optic please.Thank you to plan the recovery of the package containing it for wednesday 16/12 afternoon at the pharmacy, inside, there will also be the shaver (b)(6) which leaves in revision please.Similar event in per 2535972".Thibaut picard (sr manager procare france & benelux) requested the opening of a pi for a replacement under warranty.Updated information indicated that there was an image problem with scope.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be contact with another instrument such as a cutter, or burr during activation or sterilization, and/or rough handling during product transport or sterilization.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.

Event Description

It was reported that there was loss of image.

• Brand Name: PRECISION IE 4K EYEPIECE ARTHROSCOPE, AUTOCLAVABLE, 4MM X 30, 140MM, SPEED-LOCK
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11165019
• MDR Text Key: 227820097
• Report Number: 0002936485-2021-00022
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07613327405958
• UDI-Public: 07613327405958
• Combination Product (y/n): N
• PMA/PMN Number: K183470
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0502-444-030
• Device Catalogue Number: 0502444030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Date Manufacturer Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1