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

Catalog Number UNK_END

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The part number is unknown at this time, therefore the gtin and 510k are also unknown.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 surgery was cancelled while the patient was prepped and under anesthesia.There were no incisions made at the time of cancellation.

Event Description

It was reported that the surgery was cancelled while the patient was prepped and under anesthesia.There were no incisions made at the time of cancellation.

Manufacturer Narrative

The product was not returned for investigation; therefore, the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Probable root cause for the reported failure involving this device could not be determined due to insufficient information.The device manufacture date is not known.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.

• Brand Name: UNKNOWN_ENDOSCOPY_PRODUCT
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10083173
• MDR Text Key: 192151588
• Report Number: 0002936485-2020-00206
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/28/2020
• Initial Date FDA Received: 05/22/2020
• Supplement Dates Manufacturer Received: 04/28/2020
• Supplement Dates FDA Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR