MAUDE Adverse Event Report: RAYNHAM SURG PATXRAY 1/4X1/4-200; SURGICAL PATTIES

Model Number	80-1399
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported a surgical patty (id 801399) was placed in situ on the brain.However, when surgeon went to remove patty by pulling the string, the string came away and left the patty in situ.The patty was removed from brain after it was noticed to be still in situ after pulling the string off.When the patty was placed on the brain it was not moistened as it was already in situ to absorb blood.The patties were moistened with ringers solution within 5 minutes prior to use.It was not altered or cut from the original size prior to use, and no delay of the procedure was reported.Surgical procedure: retro sigmoid repair of right mastoid encephalocele.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The surgical patty (828810pl) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined.However, the reporter stated that the surgeon pulled on the string when removing the patties, which is against the intended use as laid out in the ifu.The ifu for the product explicitly states to not remove patties by pulling on the string.Therefore, the root cause of this complaint is improper use of product (removing patties by pulling on the string).If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: SURG PATXRAY 1/4X1/4-200
• Common Device Name: SURGICAL PATTIES
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16946524
• Report Number: 3014334038-2023-00068
• Device Sequence Number: 6376261
• Product Code: HBA
• UDI-Device Identifier: 20886704036477
• UDI-Public: 20886704036477
• Combination Product (Y/N): N
• PMA/510(K) Number: K880402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2023

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 Expiration Date: 01/31/2023
• Device Model Number: 80-1399
• Device Catalogue Number: 801399
• Device Lot Number: HR2768
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/01/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 06/05/2023
• Date Device Manufactured: 02/20/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Patient Sex: Male