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

Model Number 8010010H

Device Problems Crack (1135); Melted (1385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/05/2022

Event Type  malfunction  

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 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 Description

N/a.

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.

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
• Type of Device: 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
• MDR Text Key: 305380808
• Report Number: 3014334038-2022-00185
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10381780514565
• UDI-Public: 10381780514565
• Combination Product (y/n): N
• PMA/PMN Number: K083895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1