MAUDE Adverse Event Report: ENDOPLUS N/A; TENACULUM FORCEPS

Model Number	837026
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rwmic considers this mdr open.Rwmic will submit a follow up report after the device evaluation has been completed, the user facility has been contacted for additional information, and/or new information becomes available.
Event or Problem Description
It was reported by the user facility to richard wolf mic that: "inserts jaws would not close and could not get instrument through 5 mm trocar.Handle ratchet action would not close jaws.Surgeon was able to close jaws through 2nd trocar with second laparoscopic instrument" additional information: will the device be returned? no.Was the device being used on a patient when the reporting issue occurred? yes.Was there any injury or illness to the patient due to the reported issue? no.Was there any injury or illness to any other personnel due to the reported issue? no.Did the issue cause a delay in the procedure being performed? yes.How long was the delay? the procedure continued while the instrument was stuck inside the patient.Any delay was minimal.Did the delay put the patient at risk? yes.Was there a similar back-up device available for use? no.Was the scheduled procedure completed? yes.Will the customers return the item 8370.26 that had malfunctioned during the procedure? no, this instrument was returned to csr and thrown away.What actions were being done during the delay? the wolf rep was contacted to determine if the instrument could be taken apart or if cutting the handle off the instrument would free up the grasper so the instrument could be safely removed.Csr ran a test and cut up a lap instrument before bringing this option to the surgeon.What was the risk to the patient? potentially making a larger incision to remove the trocar and lap instrument together.Did the patient require any additional treatment during the delay or will require another procedure as the result of the delay? not that i am aware of.What was the patient's outcome? fine.The instrument was safely removed after forcing the grasper closed using a 2nd larger grasper.

• Brand Name: N/A
• Common Device Name: TENACULUM FORCEPS
• Manufacturer (Section D): ENDOPLUS; 750 tower road; suite a; mundelein IL 60060
• Manufacturer (Section G): ENDOPLUS; 750 tower road; suite a; mundelein IL 60060
• Manufacturer Contact: colleen tobin ; 353 corporate woods pkwy; vernon hills, IL 60061 ; 8479131113
• MDR Report Key: 12781725
• Report Number: 1418479-2021-00050
• Device Sequence Number: 11689425
• Product Code: HET
• UDI-Device Identifier: 00814334021194
• UDI-Public: 00814334021194
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K925079
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/26/2021

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
• Operator of Device: Health Professional
• Device Model Number: 837026
• Device Catalogue Number: 8370.26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown