MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES GTK14, ALEXIS CES 14CM W KII BALLOON; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number GTK14

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/02/2022

Event Type  malfunction  

Event Description

Procedure performed: uterine fibroid enucleation.Event description: [facility] medical center.We have received a report shows that part of the gtk17 bag was torn by forceps and it possibly remained in the body.This is a complaint from the market.Administrative no: (b)(4).Please refer to the complaint sheet for investigation.Additional information received on 26sep2022 via email from [name]: correct model is gtk14.Report from the sales rep: it is possible that a part of the bag was accidentally broken and dropped into the body when the bag was pushed in with [name] forceps while the tissue was being collected using gtk14.The fragment was recovered from the body cavity.The case was completed with the same one.No detail as to the damage condition, the seriousness, and the treatment to the patient was available.The sales rep said that it would be difficult to gather further additional information.Initial investigation report: the event unit was returned to us and visually inspected.The bag was fragmented (pic.1).The returned fragment was similar with the missing section on the bag in shape, and only a part was missing (pic.2).The unit will be returned to amr for further evaluation.Admin#: (b)(4).Products available for return: 1 part of a bag, 3 fragment.Patient status: details on the condition of the injury, its severity, and treatment are not available, but as of on (b)(6) the patient's condition is stable.Type of intervention: the fragment was recovered from the body cavity.The case was completed with the same one.

Manufacturer Narrative

The event unit is anticipated to return.A follow-up report will be provided upon completion of the investigation.

Event Description

Procedure performed: uterine fibroid enucleation.Event description: [facility] medical center.We have received a report shows that part of the gtk17 bag was torn by forceps and it possibly remained in the body.This is a complaint from the market.Administrative no.(b)(4).Please refer to the complaint sheet for investigation.Additional information received on 26sep2022 via email from [name]: correct model is gtk14.Report from the sales rep: it is possible that a part of the bag was accidentally broken and dropped into the body when the bag was pushed in with [name] forceps while the tissue was being collected using gtk14.The fragment was recovered from the body cavity.The case was completed with the same one.No detail as to the damage condition, the seriousness, and the treatment to the patient was available.The sales rep said that it would be difficult to gather further additional information.Initial investigation report the event unit was returned to us and visually inspected.The bag was fragmented (pic.1).The returned fragment was similar with the missing section on the bag in shape, and only a part was missing (pic.2).The unit will be returned to amr for further evaluation.Admin# (b)(4).Products available for return: 1 part of a bag, 3 fragment.Patient status: details on the condition of the injury, its severity, and treatment are not available, but as of september 12, the patient's condition is stable.Type of intervention: the fragment was recovered from the body cavity.The case was completed with the same one.

Manufacturer Narrative

A portion of the bag, along with three clear fragments were returned to applied medical for evaluation.Visual inspection noted that the fragments were from the bag, confirming the complainant¿s experience of bag fragmentation.Based on the condition of the returned bag portion and the description of the event, it is likely that the reported event was caused by an object or instrument (such as the forceps) that came in contact with the bag, resulting in a hole or tear.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: GTK14, ALEXIS CES 14CM W KII BALLOON
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 15591425
• MDR Text Key: 306652565
• Report Number: 2027111-2022-00772
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K060629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Followup
• Report Date: 12/13/2022

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
• Device Operator: Health Professional
• Device Model Number: GTK14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2022
• Supplement Dates Manufacturer Received: 09/21/2022
• Supplement Dates FDA Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: [NAME] FORCEPS