MAUDE Adverse Event Report: RAYNHAM ISOCOOL BPLR HNDL FLAT INSLTD; ISOCOOL DISPOSABLE FORCEPS

Model Number	8010010H
Medical Device Problem Codes	Crack (1135); Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2022
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 an isocool bipolar forceps handle flat style (id 8010010h) was sterilized in an autoclave and part of the handle melted, and cracks occurred at the cord connection before the procedure.It is unknown how the procedure was completed.No patient injury reported, and the event did not led to surgical delay.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Unique device identification (udi): (codman) (b)(4).The isocool bipolar forceps handle flat style (id 8010010h) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.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.
Additional Manufacturer Narrative
The isocool bipolar forceps handle flat style (id 8010010h) 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 - a visual inspection confirmed the presence of a large crack in the isocool handle near the cord connection point.During the functional test the isocool handle split in two at the large crack location.No extraneous force was applied during testing, indicating the large crack was large enough to severely weaken the isocool device.The complaint condition is confirmed.Plausible root cause of the reported failure if confirmed.Unable to determine root cause.The device did not meet the specifications.Therefore, the complaint condition could be confirmed.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Possible root cause include: inappropriate material selection for selected autoclave sterilization cycles.

• Brand Name: ISOCOOL BPLR HNDL FLAT INSLTD
• 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: 15285575
• Report Number: 3014334038-2022-00185
• Device Sequence Number: 7166967
• Product Code: GEI
• UDI-Device Identifier: 10381780514565
• UDI-Public: 10381780514565
• 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): 02/14/2023

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 Model Number: 8010010H
• Device Catalogue Number: 8010010H
• 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: 08/08/2022
• Supplement Date Received by Manufacturer: 10/07/2022; 01/24/2023
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 10/19/2022; 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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