MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BUZZ NONSTICK IRRIGATING: LENGTH: 20.6CM (8.11),; N/A

Catalog Number	NI22BS06
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
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
It was reported that when using the buzz nonstick irrigating forceps (ni22bs06) during surgery for cerebral arteriovenous malformation, it was confirmed that the device did not operate properly on wet surfaces (coagulation setting: 8w).However, it did operate properly on dry surfaces.It was used with electrosurgical generator and electrosurgical foot pedal.After replacing it with a different device (unknown name), coagulation on wet surfaces was possible.The generator, irrigation system, and cord & tubing set were not replaced.There was reportedly a delay of more than 30 minutes; however, no patient injury occurred.It was reported that following the event, an integra sales representative went to the facility to check the suspected product.There was an attempt to replicate the event by using chicken meat and saline.The product could not coagulate the meat when it was soaked in saline.It was reported that the product will not be returned for evaluation.
Additional Manufacturer Narrative
Updated fields - d4 (udi), d9, g3, g6, h2, h3, h6, h11.The suspected buzz nonstick irrigating forceps (ni22bs06) 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 issue of not functioning may be the result of physical damage to the device or incomplete connection to the generator.However, definitive 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.
Event or Problem Description
N/a.

• Brand Name: BUZZ NONSTICK IRRIGATING: LENGTH: 20.6CM (8.11),
• Common Device Name: N/A
• 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: 20015666
• Report Number: 3014334038-2024-00167
• Device Sequence Number: 7448787
• Product Code: GEI
• UDI-Device Identifier: 10381780149231
• UDI-Public: 10381780149231
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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: NI22BS06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ELECTROSURGICAL FOOT PEDAL 901001FPED; ELECTROSURGICAL GENERATOR 901001ESUO
• Patient Sex: Unknown