MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD LEROY SCALP CLIP -200; SCALP CLIPS

Catalog Number 201032

Device Problems Material Fragmentation (1261); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported the white part of the scalp clips are not closing.The devices broke, lost elasticity or the capacity to press the skin.One of the scalp clips "exploded" and a part fell in the surgical field.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.Complaint sample was returned for evaluation: dhr - no anomalies occurred during the manufacturing process.Failure analysis - the returned unit was found to work as intended, and met all acceptance criteria.The returned product underwent ash testing which tests the let-down rate of the colorant used in the scalp clips, as well as dsc testing which tests the resin used in the scalp clips, and it also underwent spectroscopic analysis and determined none of the material was contaminated with another type of material.The complaint could not be verified through failure analysis.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Even though the complaint could not be confirmed, possible root causes include using non-compatible forceps, inadequate configuration chosen, opening the scalp clip too far, or improper material selection/dimensional attributes/tolerances.

Event Description

N/a.

• Brand Name: LEROY SCALP CLIP -200
• Type of Device: SCALP CLIPS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• MDR Report Key: 11637371
• MDR Text Key: 246600878
• Report Number: 3014334038-2021-00070
• Device Sequence Number: 1
• Product Code: HBO
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 08/18/2021

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: 201032
• Device Lot Number: EN600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Initial Date Manufacturer Received: 03/23/2021
• Initial Date FDA Received: 04/08/2021
• Supplement Dates Manufacturer Received: 08/04/2021
• Supplement Dates FDA Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1