MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PRECISION IDEAL EYE 5.5 30° HD ACL LAP30; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0502503030
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device broke.Please note that the broken piece was successfully removed.
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.
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: tip of scope broke off into the patient's pelvis probable root cause: thermal destruction of epoxy improper epoxy/curing process laser welding failure use error the reported failure mode will be monitored for future reoccurrence.The manufacture date is not known.
Event or Problem Description
It was reported that the device broke.Please note that the broken piece was successfully removed.
Additional Manufacturer Narrative
The product has been physically received at stryker endoscopy, usa.Investigation as follows is based on product received.Alleged failure: cib sarah, surgery, broken piece at tip.Update: was the issue noticed prior, during, or after the procedure? during the procedure upon insertion of the scope into the port in the abdomen the small metal object fell into the port.It did not enter the patient's abdomen.It was successfully retrieved, and it was determined the piece was from the end of the scope.The scope and piece of metal were removed from the sterile field.A new scope was opened, and the case continued without delay.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be the weld on the keel tip failed, maintenance, or a manufacturing issue.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the device broke.Please note that the broken piece was successfully removed.

• Brand Name: PRECISION IDEAL EYE 5.5 30° HD ACL LAP30
• 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: 20522426
• Report Number: 0002936485-2024-00718
• Device Sequence Number: 18172475
• Product Code: GCJ
• UDI-Device Identifier: 07613327059144
• UDI-Public: 07613327059144
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 02/07/2025

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: 0502503030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 09/26/2024; 09/26/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 12/13/2024; 02/07/2025
• 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