MAUDE Adverse Event Report: RAYNHAM ISOCOOL LPT 8.5L 3.5WL 1MM; ISOCOOL DISPOSABLE FORCEPS

Model Number	8135100S
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The isocool bipolar tips 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 - one tip had no visual abnormalities, while the other tip was broken at the proximal plastic end that inserts into the handle.Therefore, the complaint is confirmed.A 6m root cause analysis was performed, and the following areas were examined; ¿man¿, ¿method¿, ¿machine¿, ¿materials¿, ¿measures¿ and ¿mother nature¿.The likely root cause is ¿man¿.The tip likely snapped due to too much force being applied while inserting into the handle.
Event or Problem Description
A facility reported that the isocool bipolar tip snapped when loading into forceps during setup.No patient contact / injury reported and the event did not led to surgical delay.The procedure was completed with a replacement product.

• Brand Name: ISOCOOL LPT 8.5L 3.5WL 1MM
• Common Device Name: ISOCOOL DISPOSABLE FORCEPS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• MDR Report Key: 11468021
• Report Number: 3014334038-2021-00041
• Device Sequence Number: 3430775
• Product Code: GEI
• UDI-Device Identifier: 10886704040132
• UDI-Public: 10886704040132
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2021

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: 12/31/2024
• Device Model Number: 8135100S
• Device Catalogue Number: 8135100S
• Device Lot Number: J6871Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1