MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN DISP PERFORATOR 11MM; DRILLS, BURRS, TREPHINES & ACC.

Catalog Number 26-1222

Device Problem Failure to Auto Stop (2938)

Patient Problem Tissue Damage (2104)

Event Date 01/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).It has been reported that the device will be returned for evaluation.Upon receipt of the device or additional relevant information, a follow-up report will be submitted.

Event Description

As reported, a perforator was utilized in a surgery for left temporal-sphenoidal brain tumor and failed to disengage.The patient was undergoing surgery for left temporo-sphenoidal brain tumour.During the surgery, the drill of trephine (trepan) did not disconnect¿.Clinical consequences ¿laceration of the dura matter and simple surgery follow up¿.

Manufacturer Narrative

Udi: (b)(4).Complaint sample was not returned to codman and no lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

Manufacturer Narrative

It was stated in error that there was no lot number provided, however, udi number and information was filled out correctly.The narrative should state: complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records found no discrepancies when the device was released.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

• Brand Name: CODMAN DISP PERFORATOR 11MM
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8345504
• MDR Text Key: 136465492
• Report Number: 1226348-2019-10108
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• PMA/PMN Number: K791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 26-1222
• Device Lot Number: J14W42
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2019
• Initial Date FDA Received: 02/15/2019
• Supplement Dates Manufacturer Received: 02/20/2019; 02/22/2019
• Supplement Dates FDA Received: 02/21/2019; 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR