MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG. SINGLE SPIKE TUBE SET; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	0250070530
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to opening sterile supplies for an or case, a piece of what looks like hair was found inside the package of a disposable item.The item was not opened.
Additional Manufacturer Narrative
Three attempts have been made to retrieve the device for evaluation, and it is yet to be received in-house.No further attempts to retrieve the device are required.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: piece of hair found inside packaging.Probable root cause: incorrect or inadequate packaging, severe shipping conditions, user error.The reported failure mode will be monitored for future reoccurrence.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that prior to opening sterile supplies for an or case, a piece of what looks like hair was found inside the package of a disposable item.The item was not opened.

• Brand Name: PKG. SINGLE SPIKE TUBE SET
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: andy dobos ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 22868654
• Report Number: 0002936485-2025-00715
• Device Sequence Number: 7632020
• Product Code: GEI
• UDI-Device Identifier: 37613327061353
• UDI-Public: 37613327061353
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K963646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2025

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: 0250070530
• Device Lot Number: 25024FG2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown