MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM VALVE PROGRAMMER ROHS; HAKIM PROGRAMMING TOOLS

Catalog Number 823190R

Device Problem Use of Device Problem (1670)

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

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

3 of 4 reports.A facility reported that 4 of their hakim valve programmers would not program the valve to the requested setting.They would jump to different settings that were not requested.All 4 of the programmers have been returned.

Event Description

N/a.

Manufacturer Narrative

The hakim programmer was returned for evaluation: device history record (dhr) - the product code: 82-3190 with lot: cthbbb sn: (b)(6), conformed to the specifications when released to stock.Failure analysis - inspection did not confirm the reported issue as no failure was identified.Inspection has no reported error message issue.Device has been reset, checked and returned to customer.The root cause of the issue reported by customer could not be determined as the device worked correctly.However, the possible root cause for this issue reported by the customer could be due a technical problem of the system.

• Brand Name: HAKIM VALVE PROGRAMMER ROHS
• Type of Device: HAKIM PROGRAMMING TOOLS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 10576831
• MDR Text Key: 208309686
• Report Number: 3013886523-2020-00123
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K003564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 823190R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Date Manufacturer Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1