MAUDE Adverse Event Report: AVID Medical, Inc. DISCECTOMY RCH 0247225 UD; Surgical Support Supply

Model Number	RCDI27-01
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, while preparing to drape the patient, the certified surgical technologist identified a hair inside the folded large drape.As a precaution, additional pre-incision antibiotics were administered to the patient.The surgeon paused the procedure to determine the appropriate course of action, resulting in an approximate 15-minute delay to the surgery.
Additional Manufacturer Narrative
The product involved in the event was not returned for evaluation.A follow-up report will be provided upon conclusion of investigation.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint: (b)(4).This information is submitted pursuant to 21cfr803 and should not be considered to be an admission that an o&m halyard, inc.Product is defective or has caused serious injury.

• Brand Name: DISCECTOMY RCH 0247225 UD
• Common Device Name: Surgical Support Supply
• Manufacturer (Section D): AVID Medical, Inc.; 9000 westmont drive; toano VA 23168
• Manufacturer (Section G): AVID Medical, Inc.; 9000 westmont drive; toano VA 23168
• Manufacturer Contact: angela bunn ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; +1(770)401-1697
• MDR Report Key: 50158093
• Report Number: 1047429-2026-00006
• Device Sequence Number: 10603079
• Product Code: OJH
• UDI-Device Identifier: 10809160481073
• UDI-Public: 10809160481073
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: RCDI27-01
• Device Catalogue Number: RCDI27-01
• Device Lot Number: HK-336980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown