MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. RANEY SCALP CLIPS; CLIPS, SCALP

Catalog Number 20-1037

Device Problems Break (1069); Crack (1135); Device-Device Incompatibility (2919)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Upon completion of the investigation a follow up report will be filed.Device not available.

Event Description

It was reported that the clip, which was repackaged and sold by a company called hogy medical, was cracked during a surgery when the surgeon was attempting to open the clip by using another manufacturer¿s forceps.The forceps¿ manufacturer is named eagle industries.It was suspected that the crack occurred due to the incompatibility of the used forceps with the clip.The same events occurred for multiple times since (b)(6) 2016 at the same hospital, and this was the first time to be notified to (b)(4).It is confirmed that the eagle industries¿ forceps was used for all cases.There is a possibility that a broken fragment left in the patient¿s body, but at this time, no adverse events are reported.No further information is provided by the hospital.Several potential lot numbers have been provided; however, the initial reported was not able to identify which specific lot number was affected.

Manufacturer Narrative

It was stated that the device was resold after being repackaged by another company.The labeling for the device indicates that the device is a single-use, sterile product and should not be resterilized.Several potential lot numbers have been provided; however, the initial reported was not able to identify which specific lot number was affected.A review of the manufacturing records for the potential lots was performed, and no discrepancies were noted.Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.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: RANEY SCALP CLIPS
• Type of Device: CLIPS, SCALP
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6432626
• MDR Text Key: 71048494
• Report Number: 1226348-2017-10179
• Device Sequence Number: 1
• Product Code: HBO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup

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 Catalogue Number: 20-1037
• Device Lot Number: UNK, MULTIPLE LOT CODES GIVEN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/01/2017
• Initial Date FDA Received: 03/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1