MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA CRW PRECISION ARC SYSTEM-POOL; STEREOTAXY

Catalog Number CRWPRECISEP

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that during assembly of the crw precision arc system-pool (crwprecisep) for a deep brain stimulation procedure, it was noted that the lateral slide screw which is normally captured had been fully detached and the lateral slide lock removed and was missing within the sterilization tray.This resulted in the case being delayed for 2 hours, with no adverse consequence to the patient.

Manufacturer Narrative

Crw precision arc system (crwprecisep) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.Based on information reported, root cause appears to be improper setup, however this is unconfirmed due to the fact that the product has not been returned for evaluation.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CRW PRECISION ARC SYSTEM-POOL
• Type of Device: STEREOTAXY
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• MDR Report Key: 12332184
• MDR Text Key: 266934982
• Report Number: 3004608878-2021-00525
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K944463
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CRWPRECISEP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1