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

Catalog Number 26-1221

Device Problem Failure to Auto Stop (2938)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

It was reported that the device will be made available for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

As reported by the affiliate, a codman perforator did not disengage tearing through the sinus, causing a considerable loss of blood, prolonging the surgery for over an hour.A second one was used to open the skull and it worked as expected.

Manufacturer Narrative

The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Udi : (b)(4).The device was returned for evaluation.The perforator was visually inspected.The unit was received significantly soiled, but no anomalies were observed.Due to the condition of the device, functional testing could not be tested as received.The device was cleaned and resleeved.Functional testing was then performed.The perforator drilled a series of holes without issue.A review of manufacturing record found that the device conformed to specification when released to stock.Based on the results of the investigation, the reported issue could not be confirmed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7598070
• MDR Text Key: 110968300
• Report Number: 1226348-2018-10399
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 26-1221
• Device Lot Number: HR9120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Date Manufacturer Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR