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

Model Number C4120

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Bowel Perforation (2668)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

The event unit is not anticipated to return.A follow-up report will be provided upon completion of the investigation.

Event Description

Name of procedure: colectomy.Detailed description of event: limited information available at the time of report.Our colorectal surgeon uses the reposable grasper, c4120.He has been having issues with the grasper tearing the colon.He mentioned the grasper use to have more padding on the end.Additional information received via email on 29jun2020 from [name].Rep spoke to the facility on wednesday and sent an email.Reached out again on friday and this morning ((b)(6) 2020).Event date: wednesday(b)(6) 2020.Procedure: colectomy.Patient status: ni.Type of intervention: ni.

Event Description

Procedure performed: lower anterior colon resection.Limited information available at the time of report.Our colorectal surgeon uses the reposable grasper, c4120.He has been having issues with the grasper tearing the colon.He mentioned the grasper use to have more padding on the end.Additional information received via email on 29jun2020 from [name] applied medical account mgr rep spoke to the facility on wednesday and sent an email.Reached out again on friday and this morning (29jun2020).Event date: wednesday june 24, 2020.Procedure: colectomy.Additional information received via email on 13jul2020 from [name], applied medical account mgr.The procedure was completed with the same device.The colon was being grasped at the time of the incident.There was damage caused to the tissue, doctor had to use a 3-0 vicryl sh to repair the colon.There was no patient injury.The patient is ok.Patient was a 72 year old male.There are no photos available.Intervention: doctor had to use a 3-0 vicryl sh to repair the colon.Patient status: ok.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation, and the lot number was not provided.As the event unit was not returned, testing was unable to be performed and the complainant¿s experience could not be replicated or confirmed.Applied medical has reviewed the details surrounding the event and is unable to determine the root cause of the event.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: C4120, 38CM GRASPER REPOS CART, 10/BX
• Type of Device: LAPAROCOPIC ACESSORIES, GYNECOLOGIC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 10248675
• MDR Text Key: 198325314
• Report Number: 2027111-2020-00498
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/08/2020

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 06/24/2020
• Supplement Dates FDA Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other