MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BUZZ NONSTICK LENGTH 11.3CM (4.45) TIP SIZE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	N11J025
Medical Device Problem Codes	Nonstandard Device (1420); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the device was not scissoring and noted the issue shortly after beginning to use the buzz nonstick length 11.3 cm (4.45) tip size (n11j025) device prior to surgery.A coating failure was suspected because excessive tissue burning was observed.It was unknown whether the excessive tissue burning occurred on a cadaver.There was no patient involvement; therefore, no injury, death, or surgical delay was reported.
Additional Manufacturer Narrative
The customer reported that the n11j025 buzz nonstick bipolar forceps were scissoring and had damaged coating, which resulted in tissue damage.No adverse consequences were reported.The product has not been returned for evaluation, despite three attempts made to retrieve it.Damage of this nature can occur due to storage or use-related issues.Per the instructions for use (ifu), "the instruments should be stored individually in their shipping carton or in a protective tray with partitions.Protect tips with cloth, gauze, or tubing if stored in drawers." the issues of scissoring and coating damage may therefore be attributed to wear or rough handling.If addition 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
Updated fields: d9, g3, g6, h2, h3, h6, h11.The buzz nonstick length 11.3cm (4.45) tip size (n11j025) was returned for evaluation.The device history record (dhr) was reviewed, and no abnormalities related to the reported issue were observed.Failure analysis: evaluation: visual/functional.The returned n11j025 forceps were in used condition.The tips met properly without issue.The insulation passed porosity testing, and no damage was visible to the insulation coating.Root cause analysis: the reported complaint was not confirmed.The returned n11j025 forceps are in used condition with proper function.The tips met properly, and the insulation was functional and undamaged.This complaint may be the result of user error or preference.

• Brand Name: BUZZ NONSTICK LENGTH 11.3CM (4.45) TIP SIZE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 23873683
• Report Number: 3014334038-2025-00154
• Device Sequence Number: 20166215
• Product Code: GEI
• UDI-Device Identifier: 10381780147756
• UDI-Public: 10381780147756
• Combination Product (Y/N): N
• PMA/510(K) Number: K051429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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 Catalogue Number: N11J025
• Device Lot Number: AN2506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown