MAUDE Adverse Event Report: RAYNHAM RHTN NN-STK MF, 8 7/8IN, 1.5MM; REUSABLE FORCEPS

Catalog Number 802959

Device Problem Component Missing (2306)

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

Event Date 08/19/2022

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 missing plastic stopper from bipolar forceps (id 802959)."¿i relieved the scrub nurse from a neuro surgery case.It was a navigation guided brain biopsy which has roughly got a 5cm scalp incision, the dura was breached by the brain biopsy needle.Tray sent to cssd for processing & staff noticed that the small white, round plastic stopper located in between the bipolar prong (close to the end where the lead is connected) was missing.During the time i was scrubbed we did not use the bipolar forceps & i did not notice the plastic stopped missing.The floor coordinator was informed by cssd about this & she rang the previous scrub person to inquire about this.He could not remember if the plastic piece was there when he started the case." action taken at time: floor coordinator informed the surgeon that the patient needs to have x-ray done to confirm if the missing plastic piece is in the wound.A ct scan was performed and does not have any evidence of a foreign body in the patient.Patient was fine.

Manufacturer Narrative

The forceps (802959) was returned for return.Unique device identification (udi): (b)(4).Failure analysis - the product was returned for failure analysis and the following was noted- a visual inspection showed the stopper was indeed missing from the forceps.Therefore the complaint condition could be confirmed.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Product was received for analysis and the analysis could confirm the complaint condition but the root cause remains undetermined.Possible root cause includes: incorrect tip profile or material selection.

• Brand Name: RHTN NN-STK MF, 8 7/8IN, 1.5MM
• Type of Device: REUSABLE 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: 15370639
• MDR Text Key: 305604042
• Report Number: 3014334038-2022-00199
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K963499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 802959
• Device Lot Number: 000191-002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/19/2022
• Initial Date FDA Received: 09/07/2022
• Supplement Dates Manufacturer Received: 11/11/2022
• Supplement Dates FDA Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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