MAUDE Adverse Event Report: AESCULAP, INC. RANEY CLIP; CLIP, SCALP, RANEY

Model Number FF013P

Device Problem Component Missing (2306)

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

Event Date 07/01/2015

Event Type  malfunction  

Event Description

There are two human factor related design issues with this product: it is difficult to count the raney clips because of the product packaging design.It is challenging to complete an accurate initial count because the packaging does not allow visibility of all the clips before opening.The product is; 1 magazine, 10 clips.The product should have radiopaque markers for visibility under x-ray and to aid in preventing retained surgical items.This has happened multiple times where the patient was sent to ct, when a clip was found missing.

• Brand Name: RANEY CLIP
• Type of Device: CLIP, SCALP, RANEY
• Manufacturer (Section D): AESCULAP, INC.; 3773 corporate pkwy.; center valley PA 18034
• MDR Report Key: 5100571
• MDR Text Key: 26650142
• Report Number: 5100571
• Device Sequence Number: 1
• Product Code: HBO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Model Number: FF013P
• Device Catalogue Number: FF013P
• Device Lot Number: UNKNOWN
• Other Device ID Number: FF013P
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/25/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1