MAUDE Adverse Event Report: PRO MED INSTRUMENTS INC. DORO SKULL CLAMP; HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

Device Problem Mechanical Problem (1384)

Patient Problem Laceration(s) (1946)

Event Date 03/18/2022

Event Type  malfunction  

Event Description

In operating room for c1-2 tumor resection with intradural/extradural approach and microdissection of the tumor.After final prone position, secured in the skull clamp, it was noted that the skull pin clamp had not maintained pressure from 80lb and went to 40lb.The patient sustained a laceration that needed to be sutured.

• Brand Name: DORO SKULL CLAMP
• Type of Device: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• Manufacturer (Section D): PRO MED INSTRUMENTS INC.; 4529 se 16th place, suite 101; cape coral FL 33904
• MDR Report Key: 14257435
• MDR Text Key: 290448861
• Report Number: 14257435
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/21/2022,04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/21/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18250 DA
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Race: White