MAUDE Adverse Event Report: ENDOPLUS ENDOPLUS; GRASPER, PRODUCT CODE: HET

Catalog Number	E346SL
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the device or any information in order to begin an investigation.We have not been given the lot code or po number and therefore cannot examine the dhr.A followup report will be submitted if we receive additional information.
Event or Problem Description
Customer reported that "the jaw of the laparoscopic grasper broke off and fell into the patient.The piece was able to be retrieved with no harm to the patient.".

• Brand Name: ENDOPLUS
• Common Device Name: GRASPER, PRODUCT CODE: HET
• Manufacturer (Section D): ENDOPLUS; 750 tower road; suite a; mundelein IL 60060
• MDR Report Key: 9235046
• Report Number: 1423714-2019-00001
• Device Sequence Number: 14222625
• Product Code: HET
• UDI-Device Identifier: 00817401024517
• UDI-Public: 00817401024517
• Combination Product (Y/N): N
• PMA/510(K) Number: K925079
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/17/2019

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 Catalogue Number: E346SL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1