MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; LAP,GRASP,ATRAUM,SLIDE LOCK,ROT,5MM,35CM

Catalog Number	MDS527333SP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
Type of Reportable Event	Other
Event or Problem Description
It was reported that "tip of the instrument ( laparoscopic grasper ) is broken.".
Additional Manufacturer Narrative
The customer reported that during robotic colectomy, lysis of adhesion, when the instruments were being pulled out of the patient's abdomen, the md, assistant and scrub noticed that the tip of the laparoscopic grasper was broken.No sample or photo was received for investigation; finished good production records were reviewed, but medline was unable to review the dhr as the lot was not provided, and component trending was reviewed.At this time, the reported complaint cannot be confirmed as medline was not able to investigate the issue.The cause was updated to unconfirmed defect - sample required to determine cause, and the supplier quality team will monitor this issue for trending purposes.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: LAP,GRASP,ATRAUM,SLIDE LOCK,ROT,5MM,35CM
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kurian jokutty ; three lakes drive; northfield 60093--275
• MDR Report Key: 50933253
• Report Number: 1417592-2026-52933
• Device Sequence Number: 9509096
• Product Code: HET
• UDI-Device Identifier: 10884389959367
• UDI-Public: 10884389959367
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K925079
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Catalogue Number: MDS527333SP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Unknown