MAUDE Adverse Event Report: BOSTON ENDO-SURGICAL TECHNOLOGIES / LACEY MANUFACTURING CO., LLC. PAK NEEDLE- BEVELED/TROCAR; NEUROSURGICAL NERVE LOCATOR

Model Number PK1003

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/09/2020

Event Type  Injury  

Event Description

Surgeon was using jam sheety needles (medtronic, pk1003), tip end broke off in patient.Continued, then a second tip end broke off in patient.Fda safety report id# (b)(4).

• Brand Name: PAK NEEDLE- BEVELED/TROCAR
• Type of Device: NEUROSURGICAL NERVE LOCATOR
• Manufacturer (Section D): BOSTON ENDO-SURGICAL TECHNOLOGIES / LACEY MANUFACTURING CO., LLC.
• MDR Report Key: 10294998
• MDR Text Key: 199686639
• Report Number: MW5095580
• Device Sequence Number: 1
• Product Code: PDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2023
• Device Model Number: PK1003
• Device Lot Number: BE4063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/17/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 100