MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; GLOVE,SURG, SENSICARE PI MICRO,LF,PF,6.0

Catalog Number MSG9660

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/26/2022

Event Type  Injury  

Manufacturer Narrative

According to the facility on 05/26 during the middle of the procedure the surgeon's glove tore and the piece had to be removed with a grasper device after being located laparoscopically.Per the staff the piece was identified and removed immediately after noticing the tear in the glove.According to the staff there was no noted impact to the patient and the procedure was completed without further issue.Per the facility the patient is reported to be doing 'fine'.The sample has been evaluated and the complaint of a ripped glove was confirmed.However, a definitive root cause could not be determined at this time.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the facility on 05/26 during the middle of the procedure the surgeon's glove tore and the piece had to be removed with a grasper device after being located laparoscopically.

• Type of Device: GLOVE,SURG, SENSICARE PI MICRO,LF,PF,6.0
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 14759312
• MDR Text Key: 294607428
• Report Number: 1417592-2022-00087
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MSG9660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2022
• Date Manufacturer Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 70 KG