MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD DETACH ROTO-CAM HANDLE/SHAFT; DETACH SCISSORS SYSTEM

Model Number	625090H
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This is 1 of 2 reports for the handle used during this event and is linked to manufacturer report# 3014334038-2022-00257: a facility reported that during a laparoscopic cholecystectomy, the trial detach roto-cam handle/shaft (625090h) did not function properly; the insert did not fit/link with the handle.No patient injury, death or surgical delay was reported.
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.
Additional Manufacturer Narrative
The loaner detach roto-cam handle/shaft (625090h) has been returned for evaluation.The device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Visual evaluation noted that the roto-cam handle/shaft was received in used condition with the shaft unable to link to the handle due to wear/environmental damage causing misalignment.The reported complaint was confirmed.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
N/a.

• Brand Name: DETACH ROTO-CAM HANDLE/SHAFT
• Common Device Name: DETACH SCISSORS SYSTEM
• 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: 15801224
• Report Number: 3014334038-2022-00256
• Device Sequence Number: 16909873
• Product Code: KNF
• UDI-Device Identifier: 10381780151777
• UDI-Public: 10381780151777
• Combination Product (Y/N): N
• PMA/510(K) Number: K932456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2022

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: 625090H
• Device Catalogue Number: 625090H
• Device Lot Number: 52819AB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 12/06/2022
• 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