MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN DISPOSABLE PERFORATOR; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)

Model Number 26-1221

Device Problem Mechanical Problem (1384)

Patient Problem Tissue Damage (2104)

Event Date 12/17/2018

Event Type  malfunction  

Event Description

When using codman perforator #26-1221, lot #hd2652, and expiration date 06/30/2022, on the fourth pass through cranium, neurosurgeon reports perforator did not stop and touched intracranial tissue while powered.Use of the device was discontinued, and the perforator was sequestered in sterile cup by relief scrub technician #1, and removed from sterile field by relief circulating nurse.The evening charge nurse was notified and the operating room (or) manager notified by evening charge nurse.Evening charge nurse provides directions per or manager; perforator and its labeled box held at or desk for or manager: stryker core handpiece be sent to central processing with written instructions to be processed, and to be labeled not for patient use, return to or manager asap; evening charge nurse stated she talked with processing and informed them of the same instructions; additionally, stryker core motor #5400-050-000 sn #(b)(4) placed by desk with label not to use, hold for manager.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8178238
• MDR Text Key: 130791147
• Report Number: 8178238
• Device Sequence Number: 1
• Product Code: HBF
• 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: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26-1221
• Device Catalogue Number: 261221
• Device Lot Number: HD2652
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13870 DA