MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE AIR MENISCUS SYSTEM, CURVED; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number 4720

Device Problems Device Reprocessing Problem (1091); Tear, Rip or Hole in Device Packaging (2385)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2020

Event Type  malfunction  

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 there was a breach in the sterile barrier.

Manufacturer Narrative

Alleged failure: it was reported that the hospital staff noticed a puncture to the front corner of the foil packaging on the new air device.Ahs mdip # 8825.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) severe shipping conditions or 2) user mishandling.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacturing date is unknown.

Event Description

It was reported that there was a breach in the sterile barrier.

• Brand Name: AIR MENISCUS SYSTEM, CURVED
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11268655
• MDR Text Key: 230946627
• Report Number: 0002936485-2021-00056
• Device Sequence Number: 1
• Product Code: GAT
• UDI-Device Identifier: 07613327375404
• UDI-Public: 07613327375404
• Combination Product (y/n): N
• PMA/PMN Number: K153087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 04/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4720
• Device Catalogue Number: 4720
• Device Lot Number: 7004435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1