MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4120, 38CM GRASPER REPOS CART, 10/BX; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number C4120

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/14/2022

Event Type  Injury  

Event Description

Procedure performed: colon resection.Event description: during the case the surgeon was using the device to grasp bowel and mesentery.Bleeding was noted on these tissues.The grasper was the only device used to grab bowel during the case.It is unknown how the bleeding was addressed during this procedure.The case was completed but two days later the patient had to have a second operation.It is unknown what was the reason for the second procedure and if the device contributed to the need for this second operation.During the second procedure it was noted that there was bleeding on the small bowel.It is unknown how the bleeding was addressed during this second procedure.The case was completed and the patient is currently in the hospital.Patient status is okay.Product is not available for return.The product was disposed of after the first case.Additional information received by email on (b)(6) 2022 from [name], applied medical account manager i: the first case was on (b)(6) 2022 and the second procedure was on (b)(6) 2022.Additional information received by phone on (b)(6) 2022 from [name], applied medical account manager i: the rep spoke with the surgeon about the case and the patient.The patient is currently in the icu at [user facility] (as of (b)(6) 2022.The surgeon thinks that the patient might need a third operation but the patient status is not currently good enough for the procedure.The surgeon believes that the tissue damage caused by the grasper to the bowel is the cause of the patient needing a second procedure and the patient's current status.The hospital is unable to provide a video of the procedure.Additional information received by phone on (b)(6) 2022 from [name], applied medical account manager i: i just spoke with dr.[name] and the patient was released from the hospital a few days ago.He also said that they did locate a copy of the video from the first case.The patient did not need the third operation.I don¿t know if patient needed a blood transfusion.Intervention: patient underwent second operation.It is unknown if the procedure was necessary due to this event.Patient status: patient had a second operation 2 days after the initial procedure.As of (b)(6) 2022 the patient currently in the icu.Patient may need third surgery.Patient status not currently good enough for this third procedure.

Manufacturer Narrative

No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and related products.At this time, applied medical is unable to determine the root cause of the injury or confirm that a product malfunction occurred.The probability and criticality of the harm resulting from this failure have been evaluated and were found to be at an acceptable level.

Event Description

Procedure performed: colon resection.Event description: during the case the surgeon was using the device to grasp bowel and mesentery.Bleeding was noted on these tissues.The grasper was the only device used to grab bowel during the case.It is unknown how the bleeding was addressed during this procedure.The case was completed but two days later the patient had to have a second operation.It is unknown what was the reason for the second procedure and if the device contributed to the need for this second operation.During the second procedure it was noted that there was bleeding on the small bowel.It is unknown how the bleeding was addressed during this second procedure.The case was completed and the patient is currently in the hospital.Patient status is "okay".Product is not available for return.The product was disposed of after the first case.Additional information received by email on 19apr2022 from [name], applied medical account manager i: the first case was on (b)(6) 2022 and the second procedure was on (b)(6) 2022.Additional information received by phone on 28apr2022 from [name], applied medical account manager i: the rep spoke with the surgeon about the case and the patient.The patient is currently in the icu at [user facility] (as of 28apr2022).The surgeon thinks that the patient might need a third operation but the patient status is not currently good enough for the procedure.The surgeon believes that the tissue damage caused by the grasper to the bowel is the cause of the patient needing a second procedure and the patient's current status.The hospital is unable to provide a video of the procedure.Additional information received by phone on 10may2022 from [name], applied medical account manager i: "i just spoke with dr.[name] and the patient was released from the hospital a few days ago.He also said that they did locate a copy of the video from the first case." "the patient did not need the third operation.I don¿t know if patient needed a blood transfusion" intervention: patient underwent second operation.It is unknown if the procedure was necessary due to this event.Patient status: "the patient was released from the hospital a few days ago.The patient did not need the third operation".

• Brand Name: C4120, 38CM GRASPER REPOS CART, 10/BX
• Type of Device: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• 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: 14414683
• MDR Text Key: 293627301
• Report Number: 2027111-2022-00601
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 00607915116866
• UDI-Public: (01)00607915116866(17)250201(30)01(10)1443581
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: C4120
• Device Catalogue Number: 101472471
• Device Lot Number: 1443581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/19/2022
• Initial Date FDA Received: 05/17/2022
• Supplement Dates Manufacturer Received: 04/19/2022
• Supplement Dates FDA Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2022
• 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
• Patient Outcome(s): Other