MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, ATRAUMATIC FORCEPS, DOUBLE ACTION; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Model Number 0250080311

Device Problems Material Fragmentation (1261); Device Fell (4014)

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

Event Date 01/13/2022

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 screw fell out and potentially remained inside the patient.

Event Description

It was reported that screw fell out and potentially remained inside the patient.

Manufacturer Narrative

The device manufacture date is not known.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: mid-case a screw was loosened from a manual lap instrument.The screw was lost in the patient.Probable root cause: use error.Manufacturing/ servicing errors.The reported failure mode will be monitored for future reoccurrence.

• Brand Name: PKG, ATRAUMATIC FORCEPS, DOUBLE ACTION
• Type of Device: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, 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: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 13502178
• MDR Text Key: 285386960
• Report Number: 0002936485-2022-00069
• Device Sequence Number: 1
• Product Code: OCZ
• UDI-Device Identifier: 07613327052848
• UDI-Public: 07613327052848
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/24/2022

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
• Device Operator: Health Professional
• Device Model Number: 0250080311
• Device Catalogue Number: 0250080311
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 02/09/2022
• Supplement Dates Manufacturer Received: 01/13/2022
• Supplement Dates FDA Received: 03/24/2022
• 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