MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) DUO LITHIUM ION BATTERIES - QUANTITY TWO; PFM05

Catalog Number	90622
Medical Device Problem Codes	Premature Discharge of Battery (1057); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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
A facility reported that the duo lithium-ion batteries - quantity (b)(4) (90622) does not fully charge and does not last long after charging, causing significant delays in the operating room.It was further reported that "during surgery, the batteries would run out quickly and not charge", causing an increase in surgical time of more than 30 minutes.Additionally, in some cases staff "used batteries that still worked, in others they used the light from the operating room lamp and other times they used the cable ac directly connected to the wall"; however, the surgeon was dissatisfied.It was reported that no patient injury occurred.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h11.The duo lithium ion batteries - quantity two (90622) was not was not returned to the manufacturer; therefore, an evaluation of the device could not be performed.Based on the reported complaint, the probable root cause for this duo lithium ion battery being defective could be due to a malfunctioning battery charger.However, a definite root cause cannot be identified at this time.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.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h11.The duo lithium-ion batteries - quantity two (90622) was returned for evaluation.Failure analysis: the returned duo lithium-ion batteries were in used condition.A visual/functional check was performed on the batteries.There are no visual problems with the batteries, and they are able to charge to full with a 90624us charger without issue.The reported complaint could not be duplicated.No manufacturing, workmanship, or material deficiency has been identified.Root cause: the reported complaint was not confirmed.The batteries were able to fully charge using a 90624us charger.The issue of the batteries not performing properly could be due to a malfunctioning charger.The reported complaint could not be duplicated.

• Brand Name: DUO LITHIUM ION BATTERIES - QUANTITY TWO
• Common Device Name: PFM05
• Manufacturer (Section D): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21344830
• Report Number: 3006697299-2025-00016
• Device Sequence Number: 20792244
• Product Code: FSR
• UDI-Device Identifier: 10381780490708
• UDI-Public: 10381780490708
• Combination Product (Y/N): N
• PMA/510(K) Number: 510K EXEMPT
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2025

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: 90622
• Device Lot Number: 1849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2025
• Supplement Date Received by Manufacturer: 04/10/2025; 10/16/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 05/07/2025; 10/27/2025
• 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