MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PIVOT GUARDIAN, FRAME; APPARATUS, TRACTION, NON-POWERED

Model Number	3105000100
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Serious Injury
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 sales representative got slivers of the device in their finger while wiping it down which required intervention to remove.
Additional Manufacturer Narrative
The product was not returned for investigation and the reported failure mode was not confirmed.Alleged failure: foreign silver material on user fingers probable root cause: design: * poor material selection.(easily scratched, dented, chipped).(easily torn, frayed, etc).* improper packaging design.Process: * insufficient cleaning process or abrasive cleaning.* improper finishing process.* improper screen printing.* improper handling in mgf.* use of wrong packaging components.Application: * poor handling during shipping.* subassemblies are dropped and damaged during assembly/disassembly for service.* exposure to air/surrounding environment leads to foam discoloration.¿ use errors.The device manufacture date is not known.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the sales representative got slivers of the device in their finger while wiping it down which required intervention to remove.
Additional Manufacturer Narrative
The product was not returned for investigation and the reported failure mode was not confirmed.Alleged failure: foreign silver material on user fingers probable root cause: design: sharp edges along device, material cracks creating sharp edges (01d), sharp edges on velcro.Process: sharp edges not removed during finishing operations.The device manufacture date is not known.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the sales representative got slivers of the device in their finger while wiping it down which required intervention to remove.

• Brand Name: PIVOT GUARDIAN, FRAME
• Common Device Name: APPARATUS, TRACTION, NON-POWERED
• 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: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 14879258
• Report Number: 0002936485-2022-00405
• Device Sequence Number: 19304379
• Product Code: HST
• UDI-Device Identifier: 07613327380361
• UDI-Public: 07613327380361
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/29/2022

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
• Operator of Device: Other
• Device Model Number: 3105000100
• Device Catalogue Number: 3105000100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 06/22/2022; 06/22/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 09/19/2022; 11/29/2022
• 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 Sex: Unknown