MAUDE Adverse Event Report: O&M HALYARD, INC. HYH LAP DRAPE STERL

Model Number	48050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported an issue with the robotic drape with attached leggings, noting that the seams on the leggings are coming apart.Customer reported no patient injury or medical treatment was required.Additional information was requested on (b)(6) 2025, (b)(6) 2025, and (b)(6) 2025.No responses have been received to-date.
Additional Manufacturer Narrative
Incident one of two.The product involved in the event was not returned for evaluation.Upon completion of the investigation, a follow up report will be filed.This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that product is defective or caused serious injury.
Additional Manufacturer Narrative
Based on the results of the investigation, the issue was confirmed from the photo provided.The image indicates insufficient adhesive in the legging component.However, because no sample was returned, it could not be determined whether the adhesive was missing entirely or improperly applied.A review of the drape device history record confirmed that the lot met all manufacturing process and quality requirements prior to release, and no rework or special conditions were reported.Cleaning records associated with the manufacturing process were reviewed with no issues identified.A visual inspection of the current warehouse inventory for the affected component also revealed no abnormalities.All quality inspections had been completed in accordance with procedures.Fl70104 line¿s personnel were retrained in job aid ja-07688 gluing generic instruction to reinforce good manufacturing practices and avoid recurrence on this issue.Personnel of the manufacturing line were notified of the incident for heightened awareness.The complaint has been logged in the tracking and trending program to monitor for any emerging trends.This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that product is defective or caused serious injury.

• Brand Name: HYH LAP DRAPE STERL
• Common Device Name: HYH LAP DRAPE STERL
• Manufacturer (Section D): O&M HALYARD, INC.; 1220 old alpharetta road; suite 320; alpharetta GA 30005
• Manufacturer (Section G): O&M HALYARD, INC. LA ADA DE ACUNA, S. DE. R. L. DE C. V.; av. hidalgo no. 6 esq.; blvd. luis donaldo colosio; col.educativa, nogales sonora
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta road; suite 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 23819112
• Report Number: 3005997949-2025-00013
• Device Sequence Number: 10067133
• Product Code: PUI
• UDI-Device Identifier: 10680651480504
• UDI-Public: 10680651480504
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): Unknown
• 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): 01/09/2026

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
• Operator of Device: Health Professional
• Device Model Number: 48050
• Device Catalogue Number: 48050
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/09/2026
• 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
• Patient Sex: Unknown