MAUDE Adverse Event Report: AESCULAP AG SCALPFIX STERILE; DISPOSABLE SCALP CLIPS

Model Number FF013P

Device Problem Packaging Problem (3007)

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

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: on-going.

Event Description

Per facility medwatch received: there are two human factor related design issues with this product.It is difficult to count the raney clips because of the product pacakaging 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.

Manufacturer Narrative

(b)(4).The surgeon mentioned that the scalpfix clips are not visible in the magazine and they can therefore not be counted.During manufacturing, there is a 100% visual inspection to ensure each magazine is loaded with 10 clips.It is therefore possible to count the clips used in surgery and to calculate the remaining clips in the magazine.The intended use of the device is for clip placement prior to opening the skull and removal prior to skull closing, therefore, the clips being placed are visible at all times.The clips should not be placed within the skull, therefore, there should not be the opportunity of a retained clip.If a clip were to fall into the skull from its placed location, the size and color of the clip makes it immediately visible.It was suggested that the clips be equipped with radiopaque markers.Based on the intended use of this device, it is not necessary to equip the clips with radiopaque markers.This is not a required feature of this product as the clips are applied externally and for temporary use.If used in any other manner, it would be considered off-label.The product is not available for investigation.A review of the manufacturing process was completed.No product investigations or analyses was carried out.The batch number(s) were not reported, so the production process in general was evaluated in relation to a systematic failure.There were no indications for a systematic error during the manufacturing process.Based on the evaluation of the complaint, as noted above, no containment or other remedial action(s) is necessary.The ifu clearly describes indicators and precautions for use.There are no actions planned or implemented.According to the evaluation of the complaint there is no need for remedial action(s).This is supported by complaint trend analysis.In addition to this complaint, there have been two market feedbacks from (b)(6) (no report of incidents).Due to regulatory requirements in (b)(6) the surgery equipment must be counted before and after the surgery.

Event Description

Response to request for information sent on 12/11/2015.

• Brand Name: SCALPFIX STERILE
• Type of Device: DISPOSABLE SCALP CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5185073
• MDR Text Key: 30240681
• Report Number: 2916714-2015-00941
• Device Sequence Number: 1
• Product Code: HBO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FF013P
• Device Catalogue Number: FF013P
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other