MAUDE Adverse Event Report: RAYNHAM ISOCOOL LPT 8.5L 3.5WL .5MM; ISOCOOL DISPOSABLE FORCEPS

Model Number	8135050S
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A facility reported a nurse noticed an eyelash inside the sterile packet that was still sealed.No patient consequences.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Product id corrected.Additional information received: the even did not led to surgical delay.
Additional Manufacturer Narrative
The isocool disposable forceps was returned for evaluation.Device history record (dhr) - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the isocool unit was inspected and it was noted that there was a hair present on the forceps tips in the package.The complaint could be verified through failure analysis.The complaint was confirmed in the complaint investigation.Per the failure analyst, the hair was noted inside the forceps package.The likely root cause would be operator error, a failure to inspect the packaging for particulate.Currently the complaint issue does not represent an adverse trend, however the issue will continue to be monitored and trended through the complaint evaluation process.The risk remains acceptable per the risk analysis.

• Brand Name: ISOCOOL LPT 8.5L 3.5WL .5MM
• Common Device Name: ISOCOOL DISPOSABLE FORCEPS
• 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: 14174794
• Report Number: 3014334038-2022-00082
• Device Sequence Number: 6253971
• Product Code: GEI
• UDI-Device Identifier: 10381780517313
• UDI-Public: 10381780517313
• Combination Product (Y/N): N
• PMA/510(K) Number: K083895
• 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,Followup
• Report Date (Section B): 08/23/2022

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: 11/30/2025
• Device Model Number: 8135050S
• Device Catalogue Number: 8135050S
• Device Lot Number: J92T30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 04/27/2022; 08/11/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 05/18/2022; 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2020
• 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 Sex: Unknown