MAUDE Adverse Event Report: AESCULAP AG SCALPFIX STERILE; SCALP CLIP SYSTEMS

Model Number FF013P

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/16/2023

Event Type  Injury  

Event Description

It was reported that there was an issue with the product ff013p - scalpfix sterile.According to the complaint description, a shunt procedure had been performed and a clip inadvertently left inside patient after closing the scalp.An additional medical intervention was required; an x-ray was taken which caused an unspecified surgical delay.Additional details were not provided, but had been requested.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Manufacturer Narrative

Additional information: a - patient data, b3 - event date, b5 - event description and patient harm updated, d4 - lot number and expiration, e1, e3, e4 - facility contact, h6 - codes updated.Investigation results: aesculap ag did not receive a product for investigation.Therefore, investigation results are based on historical data analysis, batch history review, and review of complaint description.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers and the products were found to be according to our specification valid at the time of production.There are no other similar complaints within this batch.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, revision.Conclusion/preventive measures: according to the description of the customer, there is no product related failure.There is also no indication for a material-, manufacturing- or design- related failure.In the event that the complaint sample will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigation results, a capa is not necessary.

Event Description

Additional information received via medwatch (b)(4): surgical team reported an unintentionally retained raney clip following a craniectomy despite correct clip count.The original procedure had been a cranioplasty revision, repair of cerebrospinal fluid (csf) leak, and external ventricular drain (evd) placement.The clips are not radiopaque.The patient required an additional procedure to remove the retained product.

• Brand Name: SCALPFIX STERILE
• Type of Device: SCALP CLIP SYSTEMS
• 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 18276043
• MDR Text Key: 329848728
• Report Number: 9610612-2023-00266
• 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: Foreign,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF013P
• Device Catalogue Number: FF013P
• Device Lot Number: 52829569
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 02/05/2024
• Supplement Dates FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention
• Patient Age: 19 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Hispanic