MAUDE Adverse Event Report: RAYNHAM NONSTICK MF, 6IN, .4MM TIP; REUSABLE FORCEPS

Catalog Number 802940

Device Problem Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2019

Event Type  malfunction  

Manufacturer Narrative

Udi -- (b)(4).One forcep was returned for evaluation with minor scissoring observed.On 07/30/2019, the forcep was visually inspected to check for tip alignment.The tips were slightly misaligned.Therefore, this complaint is confirmed.However, the root cause is unable to be determined.The complaint condition was replicated.The device did contribute to the complaint condition.The device did not meet specification.Device history records (dhrs) were reviewed and no anomalies were found.Based on the results of the investigation, the reported issue was confirmed.

Event Description

It was reported that when the surgeon opened the complaint product, s/he noticed that the tip was not correctly aligned.S/he noticed it before sterilization, so the device was not clinically used.No further information was provided by the hospital.

• Brand Name: NONSTICK MF, 6IN, .4MM TIP
• Type of Device: REUSABLE FORCEPS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kimberly shelly ; 325 paramount drive; raynham, MA 02767
• MDR Report Key: 8884896
• MDR Text Key: 154018596
• Report Number: 1226348-2019-00318
• 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: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/20/2019

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: 802940
• Device Lot Number: 963077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1