MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., PUMP CANNULA,5.8MM W/2 ROTATING STOPCOCKS; ACCESSORIES,ARTHROSCOPIC

Model Number	0747031550
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a piece of the product became loose and fell inside the patient.The piece of the product remained inside the patient.
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: stopcocks become loose and fall into patient.Probable root cause: adaptor wear, locking mechanism (j-lock, speedlock) wear, use error.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that a piece of the product became loose and fell inside the patient.The piece of the product remained inside the patient.

• Brand Name: PKG., PUMP CANNULA,5.8MM W/2 ROTATING STOPCOCKS
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• 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: 13544407
• Report Number: 0002936485-2022-00082
• Device Sequence Number: 11303466
• Product Code: NBH
• UDI-Device Identifier: 07613327054590
• UDI-Public: 07613327054590
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2022

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: Health Professional
• Device Model Number: 0747031550
• Device Catalogue Number: 0747031550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 04/01/2022
• 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