MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; STAPLER,SKIN,35W

Catalog Number	STAPLER35WA
Medical Device Problem Codes	Mechanical Jam (2983); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported, "two of the staplers have jammed while stapling a scalp and the handle was stuck to the stapler in the scalp." nurse practitioner used staple remover to remove the staple and thus the jammed stapler.Email received by inventory management, (b)(6), who was able to provide additional information in regards to this incident.Reporter states, incident occurred (b)(6) 2021 while a nurse practitioner (np) was attempting to staple an (b)(6)-year-old male who had sustain a scalp laceration to the back of his head.The reporter states, the first stapler jammed while in use.The np then switched that stapler with a new stapler from the same box and it happened again, the handle was stuck to the stapler in the scalp.Reporter states, "just the usual staple removal" was used to remove the staple and thus the staple remover." a third stapler and brand were utilized without incident.The patient is reported as doing well.No samples are available for return and evaluation therefore, a root cause will be difficult if not impossible to determine.Due to the reported incident, medical intervention and in an abundance of caution, this med watch is being filed.If any further relevant information is identified or obtained, a supplemental med watch will be submitted.
Event or Problem Description
It was reported, "two of the staplers have jammed while stapling a scalp and the handle was stuck to the stapler in the scalp." nurse practitioner used staple remover to remove the staple and thus the jammed stapler.

• Common Device Name: STAPLER,SKIN,35W
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12124853
• Report Number: 1417592-2021-00112
• Device Sequence Number: 4461752
• Product Code: GAG
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2021

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 Catalogue Number: STAPLER35WA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 8 YR