MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORP. KII SLEEVE TROCAR; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number 5X100MM

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/24/2020

Event Type  Injury  

Event Description

During a laparoscopic sigmoid colon resection and fistula take down procedure, the applied medical kii sleeve, item cts02 was removed at the end of the case and revealed an approx 1mm fragment broken of the tip.Pt abdomen was irrigated several times, and unable to locate the plastic fragment.No feedback from rep on what may have caused the break.Fda safety report id# (b)(4).

• Brand Name: KII SLEEVE TROCAR
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORP. ; rancho santa margarita CA 92688
• MDR Report Key: 9659222
• MDR Text Key: 177601368
• Report Number: MW5092690
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2022
• Device Model Number: 5X100MM
• Device Lot Number: 1375658
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 82