MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE ICONIX 1 WITH INTELLIBRAID TECHNOLOGY, 1.4MM ANCHOR WITH 1 STRAND #2 FORCE F; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 3910-500-512

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 01/24/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that there was foreign material in the sterile packaging.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: nurse informed that, they have found dirt and foreign body parts (two pieces black and white falled floor) when opening sterile iconix package.Customer didn¿t find those after operation.It didn¿t cause any delay or harm for the patient.Customer just took new package which was ok and continued operation.The probable root cause could be uncontrolled environmental conditions.

Event Description

It was reported that there was foreign material in the sterile packaging.

• Brand Name: ICONIX 1 WITH INTELLIBRAID TECHNOLOGY, 1.4MM ANCHOR WITH 1 STRAND #2 FORCE F
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8348759
• MDR Text Key: 136610894
• Report Number: 0002936485-2019-00063
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 37613252450338
• UDI-Public: 37613252450338
• Combination Product (y/n): N
• PMA/PMN Number: K133671
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3910-500-512
• Device Lot Number: 18172AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Date Manufacturer Received: 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1