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

Catalog Number 20-1037

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It has been reported that the device will not be returned for evaluation.Three potential lot numbers have been provided.(fk607, jk607 or jk605).Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported that the package contained clips, one more than expected.There was no surgical delay and no adverse consequence to the patient.No further information was provided by the hospital.The product will not be returned to your site.There was no reported patient harm.

Manufacturer Narrative

Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.The exact lot number of the suspected product was not provided.A range of potential lots was submitted.These lots were reviewed and no issues were identified prior to distribution.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
• MDR Report Key: 7379189
• MDR Text Key: 103948706
• Report Number: 1226348-2018-10246
• Device Sequence Number: 1
• Product Code: HBO
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/13/2018
• Initial Date FDA Received: 03/28/2018
• Supplement Dates Manufacturer Received: 05/07/2018
• Supplement Dates FDA Received: 05/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1