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

Catalog Number	0502503010
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Unspecified Gastrointestinal Problem (4491)
Date of Event	06/20/2023
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 the screen became black.The patient's gallbladder was injured and it resulted in its removal.The original planned procedure was not performed and was cancelled.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: when the scope was inserted into the hasson blunt tip trocar the viewing screen went black.Probable root cause: incorrect or unclear instructions for use incorrect optics assembly, incorrect scope adapter assembly, light cone failure (5mm or smaller), damaged light fibers, incorrectly assembled fibers, end of life wear-out, shipping damage, use error.The reported failure mode will be monitored for future reoccurrence.The manufacturing date is unknown.H3 other text : 81.
Event or Problem Description
It was reported that the screen became black.The patient's gallbladder was injured and it resulted in its removal.The original planned procedure was not performed and was cancelled.

• Brand Name: PRECISION IDEAL EYES 5.5MM 0°, HD AUTOCLAVABLE LAPAROSCOPE 30CM
• 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: vijay menon ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 17447121
• Report Number: 0002936485-2023-00753
• Device Sequence Number: 7260295
• Product Code: GCJ
• UDI-Device Identifier: 07613327059151
• UDI-Public: 07613327059151
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 0502503010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 70 KG