MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD MAGNIFYING LPE 2.5X RED R 12IN TO 15IN WRKG DIST; M5 - GENERAL SURGERY

Model Number	1-5001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The magnifying loupe, 2.5x red frame, 12in to 15in working distance (1-5001) was returned for evaluation.Device history record: no abnormalities related to the reported issue were identified.Failure analysis: evaluation of the returned magnifying loupe found the device was in used condition with the adjustment knobs disconnected.Root cause analysis: the complaint reported by the customer was confirmed.The returned magnifying loupe had its adjustment knob broken off due to rough handling/environmental damage.No manufacturing, workmanship or material deficiency has been identified.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
Event or Problem Description
It was reported that the up and down mechanism of the magnifying loupe (1-5001) was not working.No patient injury, death or surgical delay was reported.

• Brand Name: MAGNIFYING LPE 2.5X RED R 12IN TO 15IN WRKG DIST
• Common Device Name: M5 - GENERAL SURGERY
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 14751103
• Report Number: 3014334038-2022-00124
• Device Sequence Number: 11358445
• Product Code: HJH
• UDI-Device Identifier: 10381780462453
• UDI-Public: 10381780462453
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/21/2022

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
• Operator of Device: Health Professional
• Device Model Number: 1-5001
• Device Catalogue Number: 1-5001
• Device Lot Number: W2102005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 06/21/2022
• 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