MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PRECISION IDEAL EYES 10MM 45°, HD AUTOCLAVABLE LAPAROSCOPE 33CM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	0502103045
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
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 poor image.
Event or Problem Description
It was reported that there was poor image.
Additional 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 " not good picture" was confirmed.According to henke: scope evaluated as a level 3.Distal tip and fiber damaged, raised keel moisture in system and proximal end.Probably root cause for this failure is: the complaint for ¿not good picture¿ has been confirmed and is due to the customer used and handling.The reported failure mode will be monitored for future reoccurrence.

• Brand Name: PRECISION IDEAL EYES 10MM 45°, HD AUTOCLAVABLE LAPAROSCOPE 33CM
• 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: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 16103965
• Report Number: 0002936485-2023-00006
• Device Sequence Number: 20516491
• Product Code: GCJ
• UDI-Device Identifier: 07613327062144
• UDI-Public: 07613327062144
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K910132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2023

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 Model Number: 0502103045
• Device Catalogue Number: 0502103045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 02/10/2023
• 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