MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PRECISION IDEAL EYES 5.5MM 0°, HD AUTOCLAVABLE LAPAROSCOPE 30CM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 0502503010

Device Problems Fogging (1253); Poor Quality Image (1408)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2022

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 reported that there was foggy image.

Event Description

It reported that there was foggy image.

Manufacturer Narrative

The device manufacturer date is not known.This scope was not received for evaluation at stryker endoscopy.This scope was received at henke for evaluation.Based on the henke service record attached, the reported failure "damage on the distal end of the scope, causing fogging" was confirmed.According to henke: scope evaluated as a level 3.Dents on needle, bent needle, distal tip/fiber damage, shaver damage to distal tip, chipped lens in system, scratches on needle, residue on external optics.Probably root cause for this failure is: the complaint for ¿damage on the distal end of scope causing fogging¿ has been confirmed and is due to customer use and handling.The reported failure mode will be monitored for future reoccurrence.

• Brand Name: PRECISION IDEAL EYES 5.5MM 0°, HD AUTOCLAVABLE LAPAROSCOPE 30CM
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15432647
• MDR Text Key: 305893286
• Report Number: 0002936485-2022-00524
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 07613327059151
• UDI-Public: 07613327059151
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0502503010
• Device Catalogue Number: 0502503010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2022
• 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