MAUDE Adverse Event Report: ARTHROCARE CORP. FIRSTPASS SUTURE PASSER

Catalog Number 22-4035

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/12/2020

Event Type  Injury  

Event Description

It was reported that during surgery, when the doctor was using the firstpass, the clamp broke and was not opening.It was able to be opened but it was not through the suture.Afterwards, it was noticed that the tip was inside the patient and doctor would need x-rays to check where it is.No delay reported.Patient's outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h6 the device reported, used in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established.No product identification information was provided, thus a manufacturing record review could not be conducted.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: FIRSTPASS SUTURE PASSER
• Type of Device: PASSER
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10136434
• MDR Text Key: 194604430
• Report Number: 3006524618-2020-00353
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 22-4035
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 50 YR