MAUDE Adverse Event Report: RAYNHAM MF IRR/TI 8 3/4 .5MM TIP; REUSABLE FORCEPS

Model Number	802902
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/13/2022
Type of Reportable Event	Serious Injury
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 burnout of the surgical site while using a reusable forceps (b)(4).No additional information has been provided after several attempts.
Additional Manufacturer Narrative
Additional information received: patient age and gender - female / 68 years old.Name of procedure performed - microdiscectomy in l 3/4, lt.Did the reported event cause any delays in the procedure or surgery over 30 minutes? it took about one more hour to check whether csf leakages or not.What was the extent of the burn ¿ was it superficial? how large was it? damage to the dura has been identified.About 5mm x 5mm.Location of the burn? l 3/4 thecal sac.Was treatment of the burn necessary? yes, we used the dura mater supplement.What is the current status of the burn? fortunately, csf leak did not occur, but if it did, more aggressive surgery would have been performed.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The reusable forceps (id 802902) 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 forceps unit was inspected by the failure analyst.The failure analyst noted that the forceps were missing their silver tips, indicating some sort of manufacturing defect.Functional testing not recommended or needed due to defect.The complaint could be verified through failure analysis.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.A device history record (dhr) review and trending were performed as part of the evaluation.Product was received for analysis and the investigation could not confirm the complaint.The risk remains acceptable per the risk analysis.Possible root cause is ¿loss / uncontrolled thermal conductivity¿ or ¿excessive heat buildup¿.
Event or Problem Description
N/a.

• Brand Name: MF IRR/TI 8 3/4 .5MM TIP
• Common Device Name: REUSABLE 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: 14858709
• Report Number: 3014334038-2022-00138
• Device Sequence Number: 20035612
• Product Code: GEI
• UDI-Device Identifier: 10381780516248
• UDI-Public: 10381780516248
• Combination Product (Y/N): N
• PMA/510(K) Number: K963499
• 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,Followup
• Report Date (Section B): 01/19/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 802902
• Device Catalogue Number: 802902
• Device Lot Number: 985460
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 08/04/2022; 09/30/2022; 01/19/2024
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 08/23/2022; 10/12/2022; 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 68 YR
• Patient Sex: Female