MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4130, 5MMX35CM EPIX LAPA GRASPER, 10/BX; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number C4130

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

No product is being returned for evaluation and no lot # has been provided to manufacturer.A final report will be sent once the results have been analyzed.

Event Description

Procedure performed: colectomy.Rep wasn't informed of the complaint until today, december 11th, 2019 by the hospital coordinator, though the event occurred around a week ago exact date is unknown.Per rep, the screw at the end of the shaft that holds the jaws together jutted out and tissue was caught on the screw.The surgeon removed the caught tissue and proceeded to complete the case without any further issues.There was no patient injury and the product is not expected to return.Additional information was received, applied medical account manager associate, via e-mail on december 11th, 2019.The device did not break in any way.The screw head juts out as part of the devices new design.This same protrusion exists on every current device.Note, in the attached picture that the piece of metal connecting the jaw head to the device shaft is not flush with the shaft.This protrusion is where tissue can snag.Additional information was received, applied medical account manager associate, via e-mail on december 12th, 2019.Today i was able to meet with the doctor who is having issues with the redesigned grasper.She clarified that tissue is getting caught on the screw head and she even had bowel tissue tear during the procedure.She was able to repair the tear and the patient is fine.Intervention: removed the caught tissue from the screw and proceeded to complete the case with no further issues.Patient status: she was able to repair the tear and the patient is fine.

Event Description

Procedure performed: colectomy.Rep.Was not informed of the complaint until today, (b)(6) 2019 by the hospital coordinator, though the event occurred around a week ago (exact date is unknown).Per rep., the screw at the end of the shaft that holds the jaws together jutted out and tissue was caught on the screw.The surgeon removed the caught tissue and proceeded to complete the case without any further issues.There was no patient injury and the product is not expected to return.Additional information was received from [name], applied medical account manager associate, via e-mail on december 11th, 2019 "the device did not break in any way.The screw head juts out as part of the devices new design.This same protrusion exists on every current device.Note (in the attached picture) that the piece of metal connecting the jaw head to the device shaft is not flush with the shaft.This protrusion is where tissue can snag." additional information was received from [name], applied medical account manager associate, via e-mail on december 12th, 2019 "today i was able to meet with the doctor who is having issues with the redesigned grasper.She clarified that tissue is getting caught on the screw head and she even had bowel tissue tear during the procedure.She was able to repair the tear and the patient is fine." additional information was received from [name], applied medical account manager associate, via e-mail on january 13th, 2030 [name] stated that only one cer was submitted for the rivet catching on tissue as this was the only incident that involved patient injury.All other incidents that dr.[name] is referring to did not result in any patient injury, just an inconvenience and a potential for patient injury.Additional information was received from [name], applied medical account manager associate, via e-mail on january 16th, 2020.I was able to have a brief conversation with dr.[name] today.She explained that this snagging issue happens in 100% of cases when she uses the grasper, and she has done at least 30 cases.Please note that this is an estimate.She does not have time to go back and log every case for us.She also voiced an issue with the teal padding that lines the inside of the grasper handle.She has noticed that it comes loose much easier than our previously designed grasper.Frequently during cases, the teal lining will pop out of its inset without the surgeon intending to remove it.Dr.[name] stated that this also happens in nearly every one of her cases.Dr.[name] also explained that one of her partners, dr.[name], has the exact same issues with both the snagging and the handle insert coming loose.Intervention: removed the caught tissue from the screw and proceeded to complete the case with no further issues.Patient status: she was able to repair the tear and the patient is fine.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation, and the lot number was not provided.However, a photo of the event unit was provided by the complainant.Engineering observed that the rivet of the event unit was protruding off of the shaft.Based on the description of the event and the photo provided by the complainant, the reported event was caused by the protruding rivet of the event unit.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an unacceptable level.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical is currently researching possible design enhancements intended to further minimize the potential for this type of event to occur.

• Brand Name: C4130, 5MMX35CM EPIX LAPA GRASPER, 10/BX
• Type of Device: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9532784
• MDR Text Key: 176782742
• Report Number: 2027111-2019-00677
• 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: 03/06/2020

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: C4130
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 12/11/2019
• Supplement Dates FDA Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention