MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE HD 10MM 30° LAPAROSCOPE, AC; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0502859030
Medical Device Problem Codes	Poor Quality Image (1408); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that there was blurry image.
Event or Problem Description
It was reported that there was blurry image.
Additional Manufacturer Narrative
The device was not received for investigation at stryker endoscopy because it was repaired locally in poland.The technical service report indicates: "repair replacement of optics 0502859030 sn: (b)(6) for r type optics sn: (b)(6)" probable root cause: incorrectly assembled optical train.Damage to optical train.End of life wear-out.Shipping damage.Use error.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• Brand Name: HD 10MM 30° LAPAROSCOPE, AC
• Common Device Name: 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: 17733583
• Report Number: 0002936485-2023-00921
• Device Sequence Number: 5820258
• Product Code: GCJ
• UDI-Device Identifier: 07613327060171
• UDI-Public: 07613327060171
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K910132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0502859030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown