MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE UNKNOWN_ENDOSCOPY_PRODUCT; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number UNK_END

Device Problem Crack (1135)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device part number is not known at this time, therefore the gtin and 510k numbers are unknown.However, should it become available it will be provided in future reports.

Event Description

It was reported that the device cracked during the procedure.

Manufacturer Narrative

The reported device was not received for investigation; therefore the reported failure cannot be confirmed.The complaint will be closed without a detailed investigation.In the event that the device is received, the complaint will be reopened and the investigation will be updated with the new results.Probable root cause for the reported failure involving this device could not be determined due to insufficient information.In sum, the reported failure could not be confirmed since the device was not received at stryker endoscopy for investigation.H3 other text : 81.

Event Description

It was reported that the device cracked during the procedure.

• Brand Name: UNKNOWN_ENDOSCOPY_PRODUCT
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10308633
• MDR Text Key: 200814883
• Report Number: 0002936485-2020-00283
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_END
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1