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

Model Number 3105000100

Device Problems Material Fragmentation (1261); Device Contamination with Chemical or Other Material (2944)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2022

Event Type  Injury  

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 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.

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 295115559
• Report Number: 0002936485-2022-00405
• Device Sequence Number: 1
• Product Code: HST
• UDI-Device Identifier: 07613327380361
• UDI-Public: 07613327380361
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3105000100
• Device Catalogue Number: 3105000100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other