MAUDE Adverse Event Report: NOVADAQ TECHNOLOGIES SPY-PHI DRAPES ONLY (PACK OF 20); COVER, BARRIER, PROTECTIVE

Catalog Number	HH2020
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
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 a rubber band potentially remains inside the patient.
Event or Problem Description
It was reported that a rubber band potentially remains inside the patient.
Additional Manufacturer Narrative
Alleged failure: "one of the rubber band was missing during procedure, and they want to know whether it can be detected by x-ray or not.It was used during open surgery for liver.They also want to know the biocompatibility of the rubber.".Probable root cause(s): product was not received in-house at stryker endoscopy.Biocompatibility data for the rubber band is unavailable as this component it is not intended as a patient-contacting part.Testing by stryker rep in conjunction with hospital staff found that the rubber band could be visualized via x-ray under an in-vitro setting.However, root cause of issue cannot be determined as it is unknown as to whether the rubber band broke or was accidentally dislodged during handling of camera.In addition, there were no updates as to whether the rubber band was found inside the patient, necessitating medical intervention.This complaint investigation was closed based on the device not received.In the event that the device is returned or additional information received from customer, the complaint will be reopened and the investigation will be updated with new results.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text : 81.

• Brand Name: SPY-PHI DRAPES ONLY (PACK OF 20)
• Common Device Name: COVER, BARRIER, PROTECTIVE
• Manufacturer (Section D): NOVADAQ TECHNOLOGIES; 8329 eastlake drive, unit 101; burnaby; british columbia CA V5A 4 W2; CA V5A 4W2
• MDR Report Key: 11369243
• Report Number: 0002936485-2021-00106
• Device Sequence Number: 14380353
• Product Code: MMP
• UDI-Device Identifier: 10858701006329
• UDI-Public: 10858701006329
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K041501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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 Catalogue Number: HH2020
• Device Lot Number: NR
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other